The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Amcath Coagulation Probe.
| Device ID | K902555 |
| 510k Number | K902555 |
| Device Name: | AMCATH COAGULATION PROBE |
| Classification | Coagulator, Laparoscopic, Unipolar (and Accessories) |
| Applicant | INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Contact | Peter H Wettermann |
| Correspondent | Peter H Wettermann INTL. MEDICAL, INC. 175 CONNECTICUT MILLS AVE. Danielson, CT 06239 |
| Product Code | HFG |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-08 |
| Decision Date | 1990-06-20 |