The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Bioarterial Plus Arterial Blood Flow Enhancement System.
| Device ID | K131327 |
| 510k Number | K131327 |
| Device Name: | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | BIO COMPRESSION SYSTEMS, INC. 1983 HAZELWOOD ROAD Toms River, NJ 08753 |
| Contact | Maureen Garner |
| Correspondent | Maureen Garner BIO COMPRESSION SYSTEMS, INC. 1983 HAZELWOOD ROAD Toms River, NJ 08753 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-08 |
| Decision Date | 2013-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311029003 | K131327 | 000 |
| 00812311020055 | K131327 | 000 |
| 00812311020079 | K131327 | 000 |
| 00812311020086 | K131327 | 000 |
| 00812311020109 | K131327 | 000 |
| 00812311020116 | K131327 | 000 |
| 00812311021212 | K131327 | 000 |
| 00812311021625 | K131327 | 000 |
| 00812311021656 | K131327 | 000 |
| 00812311020048 | K131327 | 000 |