The following data is part of a premarket notification filed by Mark H. Friedman with the FDA for Ivc System.
| Device ID | K040317 |
| 510k Number | K040317 |
| Device Name: | IVC SYSTEM |
| Classification | Pack, Hot Or Cold, Water Circulating |
| Applicant | MARK H. FRIEDMAN 2 OVERHILL RD., STE 260 Scarsdale, NY 10583 |
| Contact | Mark H Friedman |
| Correspondent | Mark H Friedman MARK H. FRIEDMAN 2 OVERHILL RD., STE 260 Scarsdale, NY 10583 |
| Product Code | ILO |
| CFR Regulation Number | 890.5720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-09 |
| Decision Date | 2004-05-07 |
| Summary: | summary |