The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Syringe With/without Needle.
Device ID | K023271 |
510k Number | K023271 |
Device Name: | TERUMO SYRINGE WITH/WITHOUT NEEDLE |
Classification | Syringe, Piston |
Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
Contact | Sandi Lartka |
Correspondent | Sandi Lartka TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-01 |
Decision Date | 2002-12-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
54806017512410 | K023271 | 000 |
54806017511222 | K023271 | 000 |
54806017511215 | K023271 | 000 |
54806017511208 | K023271 | 000 |
54806017511192 | K023271 | 000 |
54806017511185 | K023271 | 000 |
54806017511178 | K023271 | 000 |
54806017511161 | K023271 | 000 |
54806017511154 | K023271 | 000 |
54806017511147 | K023271 | 000 |
54806017511130 | K023271 | 000 |
54806017511123 | K023271 | 000 |
54806017511116 | K023271 | 000 |
54806017511109 | K023271 | 000 |
54806017507188 | K023271 | 000 |
34806017512881 | K023271 | 000 |
54806017509427 | K023271 | 000 |
54806017511239 | K023271 | 000 |
54806017511246 | K023271 | 000 |
54806017511253 | K023271 | 000 |
54806017512403 | K023271 | 000 |
54806017511406 | K023271 | 000 |
54806017511390 | K023271 | 000 |
54806017511383 | K023271 | 000 |
54806017511376 | K023271 | 000 |
54806017511369 | K023271 | 000 |
54806017511352 | K023271 | 000 |
54806017511345 | K023271 | 000 |
54806017511338 | K023271 | 000 |
54806017511321 | K023271 | 000 |
54806017511314 | K023271 | 000 |
54806017511307 | K023271 | 000 |
54806017511291 | K023271 | 000 |
54806017511284 | K023271 | 000 |
54806017511277 | K023271 | 000 |
54806017511260 | K023271 | 000 |
54806017506976 | K023271 | 000 |