The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Amcath Disposable Biopsy Forceps.
| Device ID | K915142 |
| 510k Number | K915142 |
| Device Name: | AMCATH DISPOSABLE BIOPSY FORCEPS |
| Classification | Instrument, Biopsy, Mechanical, Gastrointestinal |
| Applicant | INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Contact | Peter Wettermann |
| Correspondent | Peter Wettermann INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Product Code | FCF |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-14 |
| Decision Date | 1992-01-10 |