The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Model Sc-3008 Sequential Circulator.
| Device ID | K043423 |
| 510k Number | K043423 |
| Device Name: | MODEL SC-3008 SEQUENTIAL CIRCULATOR |
| Classification | Sleeve, Limb, Compressible |
| Applicant | BIO COMPRESSION SYSTEMS, INC. 120 WEST COMMERCIAL AVE. Moonachie, NJ 07074 |
| Contact | Ron Motherwell |
| Correspondent | N.e. Devine, Jr. ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-13 |
| Decision Date | 2005-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311022158 | K043423 | 000 |
| 00812311021373 | K043423 | 000 |
| 00812311021366 | K043423 | 000 |