The following data is part of a premarket notification filed by Martell Medical Products, Inc. with the FDA for Piston Syringe.
| Device ID | K944941 |
| 510k Number | K944941 |
| Device Name: | PISTON SYRINGE |
| Classification | Arterial Blood Sampling Kit |
| 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 | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-07 |
| Decision Date | 1994-12-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078013741 | K944941 | 000 |