The following data is part of a premarket notification filed by Imagyn Medical, Inc. with the FDA for Imagyn Falloposcopy System.
Device ID | K963580 |
510k Number | K963580 |
Device Name: | IMAGYN FALLOPOSCOPY SYSTEM |
Classification | Falloposcope |
Applicant | IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
Contact | Debra A Rinderer |
Correspondent | Debra A Rinderer IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92656 -3917 |
Product Code | MKO |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-06 |
Decision Date | 1997-01-31 |
Summary: | summary |