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 |