SMART WAVE GS100— 510(k) K950617
Substantially Equivalent for Some IndicationsShotwell & Carr, Inc.
FDA 510(k) clearance K950617 for SMART WAVE GS100, Substantially Equivalent for Some Indications on 1995-10-13. Applicant: Shotwell & Carr, Inc.. Device class: 2.
Clearance details
- Applicant
- Shotwell & Carr, Inc.
- Product code
- Code IPF
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Dallas, TX, US
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