Company ยท US
Pascal Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2010. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2010 | K102526 | BLO2X OXYGEN BLOCKER Pascal Co., Inc. | EBF |
| Mar 16, 2009 | K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH Pascal Co., Inc. | LBH |
| Jul 7, 2004 | K040988 | ZIRCON-F PROPHYLAXIS PASTE Pascal Co., Inc. | EJR |
| Jun 9, 2004 | K040661 | RADENT PROPHY PASTE Pascal Co., Inc. | EJR |
| May 27, 2003 | K012889 | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT Pascal Co., Inc. | MED |
| May 2, 2003 | K030488 | FLUORILAQ Pascal Co., Inc. | LBH |
| Jan 17, 1992 | K912632 | OCCLUDE Pascal Co., Inc. | EFH |
| Jun 6, 1991 | K911259 | HYDENT Pascal Co., Inc. | EFH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2005 | Pascal Co Inc product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Man Terminated |
MED | K012889 |