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510(k) K851558

SURGICAL CAP CALOT by Roseburg SA — Product Code FYF

K851558 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "SURGICAL CAP CALOT". The FDA issued a decision of Substantially Equivalent on April 30, 1985. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Roseburg SA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1985
Date Received
April 16, 1985
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 Roseburg SA

  • K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE (September 1, 1994)
  • K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES (March 9, 1989)
  • K885275 — ASSENAT-BLESCHET SUNGLASSES (January 24, 1989)
  • K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES (August 26, 1988)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K874317 — POIRIER KID-ROLLER MANUAL WHEELCHAIR (November 17, 1987)
  • K872714 — S.T.A.C.E.M. EXTERNAL BREAST PROSTHESIS MAMMARY (July 21, 1987)
  • K871689 — SPECTACLE FRAME - LORRAINE (May 29, 1987)
  • K871688 — SPECTACLE FRAME - DANIELLE (May 29, 1987)
  • K870654 — EFER ARTHROSCOPE (May 14, 1987)

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)

FDA data resources