510(k) K871169 ยท KMJ Lubricant, Patient
LUBRICATING JELLY
| Applicant | H & P Industries, Inc., Franklin WI, US |
| Decision | Substantially Equivalent, Apr 1, 1987 |
| Received | Mar 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2011 | DeRoyal Processing Center Lubricating Jelly packaged as follows:
(1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA;
(2 Terminated |
KMJ | None listed |
| Jan 21, 2011 | H & P Industries, Inc. dba Triad Group Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets
Intended use: A pa Terminated |
KMJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.