The following data is part of a premarket notification filed by First Call, Inc. with the FDA for Suturing Washer.
| Device ID | K052642 |
| 510k Number | K052642 |
| Device Name: | SUTURING WASHER |
| Classification | Marker, Cardiopulmonary Bypass (vein Marker) |
| Applicant | FIRST CALL, INC. P.O. BOX 205 Derby, CT 06418 |
| Contact | Dina L Weissman |
| Correspondent | Dina L Weissman FIRST CALL, INC. P.O. BOX 205 Derby, CT 06418 |
| Product Code | MAB |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B776106961 | K052642 | 000 |