Panels › Gastroenterology, Urology › Product code FCH · Class 1

Tray, Biopsy, Without Biopsy Instruments

Regulation 876.4730

0510(k)s in 12 months (2 all time)

0recalls in 12 months (14 all time)

0recalls that name a 510(k)

Top companies in FCH

Company	510(k)s	Recalls
MEDLINE INDUSTRIES, LP - Northfield	0	5
American Contract Systems Inc.	0	3
Busse Hospital Disposables, Inc.	0	2
Custom Healthcare Systems, Inc.	0	2
Custom Medical Specialties, Inc.	0	1
Kontron Instruments, Inc.	1	0
Manan Manufacturing Co., Inc.	1	0
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables	0	1

Decided	510(k)	Device and applicant	Code
Jul 28, 1988	K882673	SIGMA 1 WOBBLER BIOPSY KIT Kontron Instruments, Inc.	FCH
Jun 18, 1985	K852105	MANAN UBK ULTRASONIC GUIDED BIOPSY KIT Manan Manufacturing Co., Inc.	FCH

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