The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Sequential Circulator Sc-2004fc-oc.
| Device ID | K171793 |
| 510k Number | K171793 |
| Device Name: | Sequential Circulator SC-2004FC-OC |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Bio Compression Systems, Inc. 120 W Commercial Ave Moonachie, NJ 07074 |
| Contact | Barbara J. Whitman |
| Correspondent | Barbara J. Whitman Bio Compression Systems, Inc. 120 W Commercial Ave Moonachie, NJ 07074 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-16 |
| Decision Date | 2017-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311021533 | K171793 | 000 |