The following data is part of a premarket notification filed by Novatech S.a. with the FDA for Novatech Talcair.
| Device ID | K151832 |
| 510k Number | K151832 |
| Device Name: | NOVATECH TALCAIR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NOVATECH S.A. Z.I. ATHELIA III - 1058, VOIE ANTIOPE La Ciotat Cedex, FR 13705 |
| Contact | Jennifer Neff |
| Correspondent | Stuart K. Montgomery BOSTON MEDICAL PRODUCTS INC. 117 FLANDERS ROAD Westborough, MA 01581 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-06 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBES109001T1 | K151832 | 000 |