The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Sequential Circulator Sc-2008-oc, Sequential Circulator Sc-2004-oc.
| Device ID | K150953 |
| 510k Number | K150953 |
| Device Name: | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-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 | 2015-04-09 |
| Decision Date | 2015-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311020697 | K150953 | 000 |
| 00812311020802 | K150953 | 000 |
| 00812311020819 | K150953 | 000 |
| 00812311020826 | K150953 | 000 |
| 00812311020833 | K150953 | 000 |
| 00812311020840 | K150953 | 000 |
| 00812311020857 | K150953 | 000 |
| 00812311020864 | K150953 | 000 |
| 00812311020888 | K150953 | 000 |
| 00812311020796 | K150953 | 000 |
| 00812311020789 | K150953 | 000 |
| 00812311020703 | K150953 | 000 |
| 00812311020710 | K150953 | 000 |
| 00812311020727 | K150953 | 000 |
| 00812311020734 | K150953 | 000 |
| 00812311020741 | K150953 | 000 |
| 00812311020758 | K150953 | 000 |
| 00812311020765 | K150953 | 000 |
| 00812311020772 | K150953 | 000 |
| 00812311020895 | K150953 | 000 |
| 00812311020963 | K150953 | 000 |
| 00812311020970 | K150953 | 000 |
| 00812311021557 | K150953 | 000 |
| 00812311021632 | K150953 | 000 |
| 00812311021649 | K150953 | 000 |
| 00812311021892 | K150953 | 000 |
| 00812311021908 | K150953 | 000 |
| 00812311021915 | K150953 | 000 |
| 00812311021922 | K150953 | 000 |
| 00812311021939 | K150953 | 000 |
| 00812311021540 | K150953 | 000 |
| 00812311021120 | K150953 | 000 |
| 00812311020987 | K150953 | 000 |
| 00812311020994 | K150953 | 000 |
| 00812311021007 | K150953 | 000 |
| 00812311021038 | K150953 | 000 |
| 00812311021045 | K150953 | 000 |
| 00812311021052 | K150953 | 000 |
| 00812311021069 | K150953 | 000 |
| 00812311021106 | K150953 | 000 |
| 00812311025982 | K150953 | 000 |