DISPOSABLE ISOLATION GOWN
FDA 510(k) clearance K851823 · decided 1985-05-17
Clearance details
- K-number
- K851823
- Device name
- DISPOSABLE ISOLATION GOWN
- Applicant
- American Threshold Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-26
- Decision date
- 1985-05-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FYC
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Enka, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.