FAR-EAST BARRIER GOWNS— 510(k) K971702
Substantially EquivalentFar East Science & Technology Development Co., Ltd.
FDA 510(k) clearance K971702 for FAR-EAST BARRIER GOWNS, Substantially Equivalent on 1997-07-08. Applicant: Far East Science & Technology Development Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Far East Science & Technology Development Co., Ltd.
- Product code
- Code FYC
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Garden Grove, CA, US
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