The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Laparoscopes.
| Device ID | K942730 |
| 510k Number | K942730 |
| Device Name: | AESCULAP LAPAROSCOPES |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Contact | Mary E Holden |
| Correspondent | Mary E Holden AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-09 |
| Decision Date | 1995-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250325493759 | K942730 | 000 |