The following data is part of a premarket notification filed by Terumo (philippines) Corporation with the FDA for Terumo(r) Needle.
Device ID | K121607 |
510k Number | K121607 |
Device Name: | TERUMO(R) NEEDLE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO (PHILIPPINES) CORPORATION 950 ELKTON BLVD Elkton, MD 21921 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-01 |
Decision Date | 2012-11-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
54806017512045 | K121607 | 000 |
74806017511929 | K121607 | 000 |
54806017511918 | K121607 | 000 |
54806017511901 | K121607 | 000 |
54806017511895 | K121607 | 000 |
54806017511888 | K121607 | 000 |
74806017511875 | K121607 | 000 |
54806017511864 | K121607 | 000 |
54806017511857 | K121607 | 000 |
74806017511844 | K121607 | 000 |
74806017511936 | K121607 | 000 |
74806017511943 | K121607 | 000 |
54806017512038 | K121607 | 000 |
54806017512021 | K121607 | 000 |
74806017512018 | K121607 | 000 |
74806017512001 | K121607 | 000 |
74806017511998 | K121607 | 000 |
74806017511981 | K121607 | 000 |
74806017511974 | K121607 | 000 |
74806017511967 | K121607 | 000 |
54806017511956 | K121607 | 000 |
74806017511837 | K121607 | 000 |