The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Absorbable Surgical Gut Suture, Plain And Chronic And Softcat Absorbable Surgical Gut Suture, Plain And Chronic.
| Device ID | K991223 |
| 510k Number | K991223 |
| Device Name: | ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC |
| Classification | Suture, Absorbable, Natural |
| Applicant | AESCULAP, INC. 13221 MARICOTTE PLACE San Diego, CA 92130 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler AESCULAP, INC. 13221 MARICOTTE PLACE San Diego, CA 92130 |
| Product Code | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-12 |
| Decision Date | 1999-04-30 |
| Summary: | summary |