STERILE HAND COVER— 510(k) K894064
Substantially EquivalentSage Products, Inc.
FDA 510(k) clearance K894064 for STERILE HAND COVER, Substantially Equivalent on 1989-08-11. Applicant: Sage Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Sage Products, Inc.
- Product code
- Code LYU
- Device class
- Class 1
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cary, IL, US
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