The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Winpette.
| Device ID | K871076 |
| 510k Number | K871076 |
| Device Name: | WINPETTE |
| Classification | Test, Erythrocyte Sedimentation Rate |
| Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
| Contact | Robert K Mcewen |
| Correspondent | Robert K Mcewen ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
| Product Code | JPH |
| CFR Regulation Number | 864.6700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-18 |
| Decision Date | 1987-03-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WINPETTE 73667359 1556671 Dead/Cancelled |
GUEST MEDICAL & DENTAL PRODUCTS AG 1987-06-19 |