The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Aspirator & Probe, Cytology, Endomet..
Device ID | K772121 |
510k Number | K772121 |
Device Name: | ASPIRATOR & PROBE, CYTOLOGY, ENDOMET. |
Classification | Curette, Suction, Endometrial (and Accessories) |
Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HHK |
CFR Regulation Number | 884.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-10 |
Decision Date | 1977-11-17 |