The following data is part of a premarket notification filed by Peachtree Medical, Inc. with the FDA for Ultimate Protective Safety Cap (ups Cap).
Device ID | K871142 |
510k Number | K871142 |
Device Name: | ULTIMATE PROTECTIVE SAFETY CAP (UPS CAP) |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | PEACHTREE MEDICAL, INC. P.O. BOX 893 Woodstock, GA 30188 |
Contact | Beckham, Med |
Correspondent | Beckham, Med PEACHTREE MEDICAL, INC. P.O. BOX 893 Woodstock, GA 30188 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-23 |
Decision Date | 1987-06-29 |