The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Bio Compression Cold Flo, Single Chamber Intermittent And Multi-chamber Sequential Models.
| Device ID | K961425 |
| 510k Number | K961425 |
| Device Name: | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | BIO COMPRESSION SYSTEMS, INC. P.O. BOX 470218 Broadview Heights, OH 44147 |
| Contact | Daniel A Kracov |
| Correspondent | Daniel A Kracov BIO COMPRESSION SYSTEMS, INC. P.O. BOX 470218 Broadview Heights, OH 44147 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-12 |
| Decision Date | 1996-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311020598 | K961425 | 000 |
| 00812311021618 | K961425 | 000 |
| 00812311021755 | K961425 | 000 |
| 00812311021762 | K961425 | 000 |
| 00812311021779 | K961425 | 000 |
| 00812311021786 | K961425 | 000 |
| 00812311021793 | K961425 | 000 |
| 00812311021809 | K961425 | 000 |
| 00812311021823 | K961425 | 000 |
| 00812311021601 | K961425 | 000 |
| 00812311021595 | K961425 | 000 |
| 00812311020604 | K961425 | 000 |
| 00812311020611 | K961425 | 000 |
| 00812311020628 | K961425 | 000 |
| 00812311020635 | K961425 | 000 |
| 00812311020642 | K961425 | 000 |
| 00812311021472 | K961425 | 000 |
| 00812311021571 | K961425 | 000 |
| 00812311021588 | K961425 | 000 |
| 00812311021830 | K961425 | 000 |
| 00812311021847 | K961425 | 000 |
| 00812311021854 | K961425 | 000 |
| 00812311021236 | K961425 | 000 |
| 00812311021243 | K961425 | 000 |
| 00812311021663 | K961425 | 000 |
| 00812311021670 | K961425 | 000 |
| 00812311021687 | K961425 | 000 |
| 00812311021694 | K961425 | 000 |
| 00812311023667 | K961425 | 000 |
| 00812311027610 | K961425 | 000 |
| 00812311020239 | K961425 | 000 |
| 00812311020222 | K961425 | 000 |
| 00812311021861 | K961425 | 000 |
| 00812311020147 | K961425 | 000 |
| 00812311020154 | K961425 | 000 |
| 00812311020161 | K961425 | 000 |
| 00812311020178 | K961425 | 000 |
| 00812311020185 | K961425 | 000 |
| 00812311020192 | K961425 | 000 |
| 00812311020215 | K961425 | 000 |
| 00812311027863 | K961425 | 000 |