The following data is part of a premarket notification filed by Martell Medical Products, Inc. with the FDA for Leur Tip Cap, Vlt Cap(tm).
| Device ID | K945454 |
| 510k Number | K945454 |
| Device Name: | LEUR TIP CAP, VLT CAP(TM) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | MARTELL MEDICAL PRODUCTS, INC. 26637 PIERCE CIRCLE Murrieta, CA 92562 -7024 |
| Contact | Michael D Martell |
| Correspondent | Michael D Martell MARTELL MEDICAL PRODUCTS, INC. 26637 PIERCE CIRCLE Murrieta, CA 92562 -7024 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078008631 | K945454 | 000 |