The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Masterson* Endometrial Biopsy Kit.
Device ID | K791765 |
510k Number | K791765 |
Device Name: | MASTERSON* ENDOMETRIAL BIOPSY KIT |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | Codman & Shurtleff, Inc. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-28 |
Decision Date | 1979-11-05 |