The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Endobutton Direct.
| Device ID | K102982 |
| 510k Number | K102982 |
| Device Name: | ENDOBUTTON DIRECT |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Deana Boushell |
| Correspondent | Deana Boushell SMITH & NEPHEW INC., ENDOSCOPY DIVISION 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-07 |
| Decision Date | 2011-01-05 |
| Summary: | summary |