The following data is part of a premarket notification filed by Smith & Nephew Inc., Endoscopy Division with the FDA for Endobutton Direct.
| Device ID | K070167 |
| 510k Number | K070167 |
| Device Name: | ENDOBUTTON DIRECT |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-18 |
| Decision Date | 2007-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885554015041 | K070167 | 000 |
| 03596010592361 | K070167 | 000 |
| 03596010592026 | K070167 | 000 |
| 03596010592019 | K070167 | 000 |
| 03596010592002 | K070167 | 000 |
| 03596010591999 | K070167 | 000 |