The following data is part of a premarket notification filed by Circon Acmi with the FDA for Usa Series Laparoscopes.
| Device ID | K013165 |
| 510k Number | K013165 |
| Device Name: | USA SERIES LAPAROSCOPES |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Contact | Wayne B Sterner |
| Correspondent | Wayne B Sterner CIRCON ACMI 300 STILLWATER AVE. P.O. BOX 1971 Stamford, CT 06904 -1971 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-21 |
| Decision Date | 2002-01-18 |
| Summary: | summary |