The following data is part of a premarket notification filed by Concord/portex with the FDA for Syringe Tip Cap.
| Device ID | K911638 |
| 510k Number | K911638 |
| Device Name: | SYRINGE TIP CAP |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Contact | Robert Wheeler |
| Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688070566 | K911638 | 000 |