The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Ic-1545-dl Multi Flo Dvt Combo Intermittent Pneumatic Compression Device.
| Device ID | K131306 |
| 510k Number | K131306 |
| Device Name: | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
| 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 | 2013-05-07 |
| Decision Date | 2013-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812311022042 | K131306 | 000 |
| 00812311020543 | K131306 | 000 |
| 00812311020567 | K131306 | 000 |
| 00812311020659 | K131306 | 000 |
| 00812311020680 | K131306 | 000 |
| 00812311021144 | K131306 | 000 |
| 00812311021885 | K131306 | 000 |
| 00812311022028 | K131306 | 000 |
| 00812311022035 | K131306 | 000 |
| 00812311020512 | K131306 | 000 |