The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Pliasure Polyglycolide Synthetic Absorbable Suture.
| Device ID | K142822 |
| 510k Number | K142822 |
| Device Name: | PLIASURE Polyglycolide Synthetic Absorbable Suture |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ETHICON, Inc. Rt. 22 West, P.O. Box 151 Somerville, NJ 08876 |
| Contact | Susan Lin |
| Correspondent | Susan Lin ETHICON, Inc. Rt. 22 West, P.O. Box 151 Somerville, NJ 08876 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-03-26 |
| Summary: | summary |