The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Amcath Disposable Trocar And Trocar Sleeve.
| Device ID | K912927 |
| 510k Number | K912927 |
| Device Name: | AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVE |
| Classification | Laparoscope, General & Plastic Surgery |
| 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-03 |
| Decision Date | 1991-09-19 |