The following data is part of a premarket notification filed by Gynecare, Inc. with the FDA for Scuba System.
| Device ID | K962482 |
| 510k Number | K962482 |
| Device Name: | SCUBA SYSTEM |
| Classification | Hysteroscope (and Accessories) |
| Applicant | GYNECARE, INC. 235 CONSTITUTION DR. Menio Park, CA 94025 |
| Contact | Milton B Mccoll, M.d. |
| Correspondent | Milton B Mccoll, M.d. GYNECARE, INC. 235 CONSTITUTION DR. Menio Park, CA 94025 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-26 |
| Decision Date | 1996-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705031000794 | K962482 | 000 |
| 20705031000787 | K962482 | 000 |
| 20705031000770 | K962482 | 000 |