The following data is part of a premarket notification filed by Post Medical, Inc. with the FDA for Diabetic Needle Disposal, Model # Pmsm - 950.
Device ID | K990371 |
510k Number | K990371 |
Device Name: | DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950 |
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 | 1999-02-08 |
Decision Date | 1999-04-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B309PMSM9501 | K990371 | 000 |