The following data is part of a premarket notification filed by Medscience, Inc. with the FDA for Recap-1.
Device ID | K960641 |
510k Number | K960641 |
Device Name: | RECAP-1 |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | MEDSCIENCE, INC. 8803 BRECKSVILLE RD., SUITE 5 Brecksville, OH 44141 -1933 |
Contact | Autumn Kliskey |
Correspondent | Autumn Kliskey MEDSCIENCE, INC. 8803 BRECKSVILLE RD., SUITE 5 Brecksville, OH 44141 -1933 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-14 |
Decision Date | 1996-05-17 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RECAP-1 74413091 1985967 Dead/Cancelled |
Kliskey Marketing 1993-07-16 |