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510(k) K771929

PEDIATRICS GOWN by Convertors — Product Code FYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1977
Date Received
October 14, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Patient
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Convertors

  • K780627 — SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (July 11, 1979)
  • K790234 — DRAPE PACKS, SURGICAL GOWNS (February 22, 1979)
  • K781959 — SURGICAL GOWNS, SHEETS (January 10, 1979)
  • K781534 — SURG-O-PAK PREP PAD (October 24, 1978)
  • K781099 — SURGICAL GOWNS AND DRAPES (August 14, 1978)
  • K780169 — MASK, SURGICAL (February 13, 1978)
  • K770933 — BIO-SHIELD CSR WRAP (September 2, 1977)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K761034 — SURGEX SURGICAL SPONGE (January 5, 1977)

Other clearances for product code FYB

  • K911921 — DISPOSABLE ISOLATION GOWN (May 13, 1991)
  • K891820 — DISPOSABLE MEDICAL GOWNS (July 24, 1989)
  • K891053 — DENTAL BIB (April 12, 1989)
  • K803171 — PROCEDURE & RECOVERY PATIENT SUIT (March 4, 1981)
  • K801570 — SHIELD DISP. PATIENTS PONCHO GOWNS (July 28, 1980)