The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Hm-0690 Colposcope.
Device ID | K932896 |
510k Number | K932896 |
Device Name: | HM-0690 COLPOSCOPE |
Classification | Colposcope (and Colpomicroscope) |
Applicant | HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
Contact | Ernesto Ackerman |
Correspondent | Ernesto Ackerman HILL-MED, INC. 7217 N.W. 46TH ST. Miami, FL 33166 |
Product Code | HEX |
CFR Regulation Number | 884.1630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-14 |
Decision Date | 1994-03-23 |