The following data is part of a premarket notification filed by Iskra.med with the FDA for Proteam Cushion.
| Device ID | K953352 |
| 510k Number | K953352 |
| Device Name: | PROTEAM CUSHION |
| Classification | Cushion, Flotation |
| Applicant | ISKRA.MED 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Milton N Beneke |
| Correspondent | Milton N Beneke ISKRA.MED 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-17 |
| Decision Date | 1995-11-29 |