GUARDIAN II GLOVE— 510(k) K945577
Substantially EquivalentGuardian Group, Inc.
FDA 510(k) clearance K945577 for GUARDIAN II GLOVE, Substantially Equivalent on 1994-12-29. Applicant: Guardian Group, Inc.. Device class: 1.
Clearance details
- Applicant
- Guardian Group, Inc.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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