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 |