The following data is part of a premarket notification filed by A.m. Surgical, Inc. with the FDA for Mountable Endoscopic Blade.
| Device ID | K080133 |
| 510k Number | K080133 |
| Device Name: | MOUNTABLE ENDOSCOPIC BLADE |
| Classification | Knife, Surgical |
| Applicant | A.M. SURGICAL, INC. 290 EAST MAIN ST. SUITE 200 Smithtown, NY 11787 |
| Contact | Vincent Pascale |
| Correspondent | Vincent Pascale A.M. SURGICAL, INC. 290 EAST MAIN ST. SUITE 200 Smithtown, NY 11787 |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-18 |
| Decision Date | 2008-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420193001 | K080133 | 000 |
| 00840420192943 | K080133 | 000 |