The following data is part of a premarket notification filed by Post Medical, Inc. with the FDA for Sharps Containment System.
Device ID | K925816 |
510k Number | K925816 |
Device Name: | SHARPS CONTAINMENT SYSTEM |
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 | 1992-11-17 |
Decision Date | 1994-04-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B309WD200Y1 | K925816 | 000 |
B3091101LPBW0 | K925816 | 000 |
B3091101LPR0 | K925816 | 000 |
B3091G1 | K925816 | 000 |
B3092201LPBW1 | K925816 | 000 |
B3092201LPBWY1 | K925816 | 000 |
B3092201LPR1 | K925816 | 000 |
B3092G1 | K925816 | 000 |
B3092GY1 | K925816 | 000 |
B3093301LPR1 | K925816 | 000 |
B3093G1 | K925816 | 000 |
B309SL1001 | K925816 | 000 |
B309SL1501 | K925816 | 000 |
B309SL2001 | K925816 | 000 |
B309WD1101 | K925816 | 000 |
B309WD1501 | K925816 | 000 |
B309WD2000 | K925816 | 000 |
00761059015017 | K925816 | 000 |