The following data is part of a premarket notification filed by Exelint International Co. with the FDA for Exel Secure Touch Safety (p.s.v.) Scalp Vein Set.
| Device ID | K010197 |
| 510k Number | K010197 |
| Device Name: | EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| Applicant | EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90231 -3194 |
| Contact | Armand Hamid |
| Correspondent | Armand Hamid EXELINT INTERNATIONAL CO. 5840 W. CENTINELA AVE. Los Angeles, CA 90231 -3194 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10020221278085 | K010197 | 000 |
| 10020221278061 | K010197 | 000 |
| 10020221278047 | K010197 | 000 |
| 10020221278689 | K010197 | 000 |
| 10020221278665 | K010197 | 000 |
| 10020221278641 | K010197 | 000 |