The following data is part of a premarket notification filed by Resorba Medical Gmbh with the FDA for Caprolon.
| Device ID | K181320 |
| 510k Number | K181320 |
| Device Name: | Caprolon |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | Resorba Medical GmbH Am Flachmoor 16 Nuremberg, DE 90475 |
| Contact | Helen Topping |
| Correspondent | Helen Topping Resorba Medical GmbH Am Flachmoor 16 Nuremberg, DE 90475 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-18 |
| Decision Date | 2018-09-18 |
| Summary: | summary |