GOWN, ISOLATION, SURGICAL (FYC)— 510(k) K882281
Substantially EquivalentA Plus International, Inc.
FDA 510(k) clearance K882281 for GOWN, ISOLATION, SURGICAL (FYC), Substantially Equivalent on 1988-06-23. Applicant: A Plus International, Inc.. Device class: 2.
Clearance details
- Applicant
- A Plus International, Inc.
- 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
- La Puente, CA, US
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More clearances from A Plus International, Inc.
view all- K213001 — Procedure Mask, Surgical Mask
- K102861 — SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
- K093169 — SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
- K031353 — SOLUTION FACE MASKS
- K882280 — COVER, SHOE OPERATING ROOM
Data sourced from openFDA. This site is unofficial and independent of the FDA.