The following data is part of a premarket notification filed by Htl-strefa S.a. with the FDA for Droplet Pen Needles.
Device ID | K143437 |
510k Number | K143437 |
Device Name: | Droplet Pen Needles |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | HTL-STREFA S.A. Adamowek 7 Ozorkow, PL 95-035 |
Contact | Aleksandra Prazmowska-wilanowska |
Correspondent | Aleksandra Prazmowska-wilanowska HTL-STREFA S.A. Adamowek 7 Ozorkow, PL 95-035 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-01 |
Decision Date | 2015-06-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50096295129132 | K143437 | 000 |
10021292009042 | K143437 | 000 |
10021292009073 | K143437 | 000 |
10021292009035 | K143437 | 000 |
10021292009059 | K143437 | 000 |
10021292009066 | K143437 | 000 |
50096295129095 | K143437 | 000 |
50096295129101 | K143437 | 000 |
50096295129118 | K143437 | 000 |
50096295129125 | K143437 | 000 |
10021292010314 | K143437 | 000 |