The following data is part of a premarket notification filed by Circon Video with the FDA for Circon Acmi Hydrolaparoscope(tm) Instrument.
| Device ID | K911053 |
| 510k Number | K911053 |
| Device Name: | CIRCON ACMI HYDROLAPAROSCOPE(TM) INSTRUMENT |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, CT 06904 -1971 |
| Contact | Ervin F Taylor |
| Correspondent | Ervin F Taylor CIRCON VIDEO 300 STILLWATER AVE. P.O. BOX BOX 1971 Stanford, 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 | 1991-03-08 |
| Decision Date | 1991-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925007291 | K911053 | 000 |
| 00821925007284 | K911053 | 000 |