The following data is part of a premarket notification filed by Care Medical Devices, Inc. with the FDA for Proguardii(tm) Blood Collection Device.
| Device ID | K913914 |
| 510k Number | K913914 |
| Device Name: | PROGUARDII(TM) BLOOD COLLECTION DEVICE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CARE MEDICAL DEVICES, INC. 1440 SOUTH CARLOS AVE. Ontario, CA 91761 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard CARE MEDICAL DEVICES, INC. 1440 SOUTH CARLOS AVE. Ontario, CA 91761 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1991-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521013759 | K913914 | 000 |
| 10884521013698 | K913914 | 000 |