The following data is part of a premarket notification filed by Intl., Inc. with the FDA for Embryo Transfer Catheter Cc Glider.
Device ID | K991266 |
510k Number | K991266 |
Device Name: | EMBRYO TRANSFER CATHETER CC GLIDER |
Classification | Catheter, Assisted Reproduction |
Applicant | INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
Contact | Michael D Cecchi |
Correspondent | Michael D Cecchi INTL., INC. 170 FORT PATH RD. UNIT 14 Madison, CT 06443 |
Product Code | MQF |
CFR Regulation Number | 884.6110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-13 |
Decision Date | 1999-09-09 |
Summary: | summary |