The following data is part of a premarket notification filed by Gainor Medical U.s.a., Inc. with the FDA for Suresharp.
Device ID | K950159 |
510k Number | K950159 |
Device Name: | SURESHARP |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | GAINOR MEDICAL U.S.A., INC. 2205 HIGHWAY 42 NORTH P.O. BOX 353 Mcdonough, GA 30253 -0353 |
Contact | William C Taylor |
Correspondent | William C Taylor GAINOR MEDICAL U.S.A., INC. 2205 HIGHWAY 42 NORTH P.O. BOX 353 Mcdonough, GA 30253 -0353 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-17 |
Decision Date | 1995-04-14 |