The following data is part of a premarket notification filed by Atc Technologies, Inc. with the FDA for Modulap Loop.
| Device ID | K121343 |
| 510k Number | K121343 |
| Device Name: | MODULAP LOOP |
| Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Applicant | ATC TECHNOLOGIES, INC. 79 HAVEN STREET Dover, MA 02030 |
| Contact | John Gillespie |
| Correspondent | John Gillespie ATC TECHNOLOGIES, INC. 79 HAVEN STREET Dover, MA 02030 |
| Product Code | KNF |
| CFR Regulation Number | 884.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-04 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817428020738 | K121343 | 000 |