The following data is part of a premarket notification filed by Sherwood Medical Industries with the FDA for Sherwood Disposable Endometrial Samples.
Device ID | K801070 |
510k Number | K801070 |
Device Name: | SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | SHERWOOD MEDICAL INDUSTRIES 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 | 1980-05-06 |
Decision Date | 1980-07-21 |