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510(k) K761070

P.S.M. SURGICAL HOOD by The Owenby Co. — Product Code FXY

K761070 is an FDA 510(k) premarket notification submitted by The Owenby Co. for the device "P.S.M. SURGICAL HOOD". The FDA issued a decision of Substantially Equivalent on December 30, 1976. The device falls under product code FXY (Hood, Surgical), a Class II device regulated under 21 CFR 878.4040. The Owenby Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1976
Date Received
November 16, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by The Owenby Co.

  • K801628 — RESTRAINT, PROTECTIVE (August 7, 1980)
  • K801626 — ARM SLING (July 28, 1980)
  • K801627 — COVER, LIMB (July 28, 1980)
  • K801532 — STOCKINETTE, STERILE TWO PLY W/PULL TABS (July 28, 1980)
  • K801531 — ARM SLING (July 21, 1980)
  • K790210 — STOCKINETTE, TUBULAR UNBLEACHED (February 27, 1979)
  • K780764 — NON-STERILE FOLDED GAUZE (June 6, 1978)
  • K780418 — BURN DRESSING PAD (April 10, 1978)
  • K770889 — BURN DRESSING KIT (July 11, 1977)
  • K761068 — P.S.M. BOUFFANT CAP (December 30, 1976)

Other clearances for product code FXY

  • K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) (October 17, 2023)
  • K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgi (March 21, 2020)
  • K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS (June 26, 2014)
  • K904969 — HOOD, OPERATING, SURGICAL (December 12, 1990)
  • K904276 — DISPOSABLE BEARD COVER (November 21, 1990)
  • K903533 — STERI-SHIELD (October 19, 1990)
  • K902677 — STERI-SHIELD (August 17, 1990)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)
  • K770261 — HOOD, CLARION SURGEONS (March 1, 1977)
  • K770257 — HOOD & BEARD COVER, CLARION SURGEON'S (February 25, 1977)

FDA data resources