The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Endoscopic Instruments.
| Device ID | K940936 |
| 510k Number | K940936 |
| Device Name: | AESCULAP ENDOSCOPIC INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-28 |
| Decision Date | 1994-04-19 |