The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for E-pack Procedure Kit.
| Device ID | K161726 |
| 510k Number | K161726 |
| Device Name: | E-Pack Procedure Kit |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ETHICON, INC. ROUTE 22 WM P.O. BOX 151 Somerville, NJ 08876 |
| Contact | Enza Deserio |
| Correspondent | Enza Deserio ETHICON, INC. ROUTE 22 WM P.O. BOX 151 Somerville, NJ 08876 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-06-22 |
| Decision Date | 2016-07-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705031241903 | K161726 | 000 |
| 30705031241576 | K161726 | 000 |
| 30705031241507 | K161726 | 000 |
| 30705031241484 | K161726 | 000 |
| 30705031241439 | K161726 | 000 |
| 30705031241422 | K161726 | 000 |
| 30705031241415 | K161726 | 000 |
| 30705031241361 | K161726 | 000 |
| 30705031241347 | K161726 | 000 |
| 30705031241620 | K161726 | 000 |
| 30705031241668 | K161726 | 000 |
| 30705031241897 | K161726 | 000 |
| 30705031241880 | K161726 | 000 |
| 30705031241873 | K161726 | 000 |
| 30705031241859 | K161726 | 000 |
| 30705031241842 | K161726 | 000 |
| 30705031241835 | K161726 | 000 |
| 30705031241712 | K161726 | 000 |
| 30705031241699 | K161726 | 000 |
| 30705031241309 | K161726 | 000 |