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510(k) K031353

SOLUTION FACE MASKS by A Plus International, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2003
Date Received
April 29, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by A Plus International, Inc.

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  • K882284 — SURGEONS CAP (June 23, 1988)
  • K882281 — GOWN, ISOLATION, SURGICAL (FYC) (June 23, 1988)
  • K882280 — COVER, SHOE OPERATING ROOM (June 23, 1988)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K881396 — OPERATING ROOM TOWELS -STERILE & NON-STERILE (April 29, 1988)
  • K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE (April 28, 1988)

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