The following data is part of a premarket notification filed by Post Medical, Inc. with the FDA for Syringe Needle Remover (s.n.r.).
Device ID | K972536 |
510k Number | K972536 |
Device Name: | SYRINGE NEEDLE REMOVER (S.N.R.) |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | POST MEDICAL, INC. P.O. BOX 29863 Atltanta, GA 30359 |
Contact | David R Thead |
Correspondent | David R Thead POST MEDICAL, INC. P.O. BOX 29863 Atltanta, GA 30359 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-08 |
Decision Date | 1997-08-15 |