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510(k) K844704

CAPS (O.R. NURSE, SURGICAL) by Medicon, Inc. — Product Code FYF

K844704 is an FDA 510(k) premarket notification submitted by Medicon, Inc. for the device "CAPS (O.R. NURSE, SURGICAL)". The FDA issued a decision of Substantially Equivalent on January 10, 1985. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Medicon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1985
Date Received
December 3, 1984
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 Medicon, Inc.

  • K962087 — SERVOTRONIC EC100 SYSTEM (April 23, 1997)
  • K952168 — TITANIUM MANDIBULAR FRACTURE SYSTEM (June 22, 1995)
  • K850855 — TENS GB1001 DEVICE (January 9, 1986)
  • K850852 — INFRARAX DEVICE (August 21, 1985)
  • K844702 — GAUZE ASORBABLE (April 1, 1985)
  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

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)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K954454 — NIOMED SURGICAL HOOD (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)

FDA data resources