Home / 510(k) Clearances / K761068

510(k) K761068

P.S.M. BOUFFANT CAP by The Owenby Co. — Product Code FYF

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
Cap, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
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)
  • K761070 — P.S.M. SURGICAL HOOD (December 30, 1976)

Other clearances for product code FYF

  • K972227 — SHOE COVER (September 9, 1997)
  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954556 — SURGICAL CAP (March 12, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K913700 — DISPOSABLE BOUFFANT CAP (October 4, 1991)
  • K882346 — INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (June 30, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)