The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Modified Coated Vicryl* Rapide (polyglactin 910) Suture.
| Device ID | K033746 |
| 510k Number | K033746 |
| Device Name: | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Rey Librojo |
| Correspondent | Rey Librojo ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-01 |
| Decision Date | 2003-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031225132 | K033746 | 000 |
| 30705031134687 | K033746 | 000 |
| 30705031134670 | K033746 | 000 |
| 30705031134663 | K033746 | 000 |
| 30705031134656 | K033746 | 000 |
| 30705031134649 | K033746 | 000 |
| 30705031134632 | K033746 | 000 |
| 30705031134625 | K033746 | 000 |
| 30705031134601 | K033746 | 000 |
| 30705031134595 | K033746 | 000 |
| 30705031134694 | K033746 | 000 |
| 30705031134700 | K033746 | 000 |
| 30705031134717 | K033746 | 000 |
| 30705031147939 | K033746 | 000 |
| 30705031134793 | K033746 | 000 |
| 30705031134786 | K033746 | 000 |
| 30705031134779 | K033746 | 000 |
| 30705031134762 | K033746 | 000 |
| 30705031134755 | K033746 | 000 |
| 30705031134748 | K033746 | 000 |
| 30705031134731 | K033746 | 000 |
| 30705031134724 | K033746 | 000 |
| 30705031133352 | K033746 | 000 |