Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
FDA 510(k) clearance K230577 · decided 2023-08-16
Clearance details
- K-number
- K230577
- Device name
- Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
- Applicant
- Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
- Decision
- Substantially Equivalent
- Date received
- 2023-03-01
- Decision date
- 2023-08-16
- Days to decision
- 168 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
- Izmir, TR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.