The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Resectoscope Safety Sheath.
Device ID | K972210 |
510k Number | K972210 |
Device Name: | RESECTOSCOPE SAFETY SHEATH |
Classification | Hysteroscope (and Accessories) |
Applicant | CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
Contact | Cindy Domecus |
Correspondent | Cindy Domecus CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos, CA 94070 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-11 |
Decision Date | 1997-09-05 |
Summary: | summary |