PROTEAM CUSHION— 510(k) K953352
Substantially EquivalentIskra.Med
FDA 510(k) clearance K953352 for PROTEAM CUSHION, Substantially Equivalent on 1995-11-29. Applicant: Iskra.Med. Device class: 1.
Clearance details
- Applicant
- Iskra.Med
- Product code
- Code KIC
- Device class
- Class 1
- Regulation
- 21 CFR 890.3175
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck,, NY, US
Recent devices under product code KIC
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