The following data is part of a premarket notification filed by Reza S Mohajer, M.d. C/o Krass & Young with the FDA for Cell Sweep.
Device ID | K911327 |
510k Number | K911327 |
Device Name: | CELL SWEEP |
Classification | Spatula, Cervical, Cytological |
Applicant | REZA S MOHAJER, M.D. C/O KRASS & YOUNG C/O KRASS & YOUNG LAW OFFICES 3001 W. BIG BEAVER RD STE 624 Troy, MI 48084 |
Contact | Ronald W Citkowski |
Correspondent | Ronald W Citkowski REZA S MOHAJER, M.D. C/O KRASS & YOUNG C/O KRASS & YOUNG LAW OFFICES 3001 W. BIG BEAVER RD STE 624 Troy, MI 48084 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-26 |
Decision Date | 1991-05-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CELL SWEEP 74131793 1709296 Live/Registered |
MEDGYN PRODUCTS, INC. 1991-01-22 |