The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Endoscopic Applicator.
| Device ID | K120608 |
| 510k Number | K120608 |
| Device Name: | ENDOSCOPIC APPLICATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD St. Paul, MN 55121 |
| Contact | Lise W Duran |
| Correspondent | Paula Wilkerson INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-02-29 |
| Decision Date | 2012-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020306 | K120608 | 000 |