The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Modification To Terumo Syringe With/without Needle.
Device ID | K063613 |
510k Number | K063613 |
Device Name: | MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE |
Classification | Syringe, Piston |
Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
Contact | Sandi Hartka |
Correspondent | Sandi Hartka TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-05 |
Decision Date | 2006-12-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
54806017511468 | K063613 | 000 |
54806017511451 | K063613 | 000 |
54806017511444 | K063613 | 000 |
54806017511437 | K063613 | 000 |
54806017511420 | K063613 | 000 |
54806017511413 | K063613 | 000 |
54806017509434 | K063613 | 000 |