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510(k) K760360

SHIRT, MITTEN CUFF INFANT by Precept, Inc. — Product Code FME

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1976
Date Received
August 2, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Examination
Device Class
Class I
Regulation Number
880.6265
Review Panel
HO
Submission Type

Other clearances by Precept, Inc.

  • K771409 — DISP. SURGICAL FACE MASK (October 27, 1977)
  • K770463 — MASK, SURGICAL, FACE, DISPOSABLE (March 23, 1977)
  • K770391 — COVER, ARMBOARD, DISPOSABLE (March 7, 1977)
  • K770021 — MASK, FACE, SURGICAL (January 17, 1977)

Other clearances for product code FME

  • K880385 — KIMBERLY-CLARK PROFESSIONAL JACKET (February 19, 1988)
  • K811915 — MONITOR/VITAL SIGNS TRAY (July 28, 1981)
  • K770476 — EXAM GOWN (May 6, 1977)
  • K760954 — CROWNTEX EXAM. CAPE & GOWN (December 30, 1976)