ATEK SURGICAL GOWNS
FDA 510(k) clearance K100971 · decided 2010-09-27
Clearance details
- K-number
- K100971
- Device name
- ATEK SURGICAL GOWNS
- Applicant
- Hangzhou Atek Medical & Textile Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-08
- Decision date
- 2010-09-27
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- FYA
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.