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510(k) K882346

INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD by Nordbye, Milchman, Barlage — Product Code FYF

K882346 is an FDA 510(k) premarket notification submitted by Nordbye, Milchman, Barlage for the device "INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD". The FDA issued a decision of Substantially Equivalent on June 30, 1988. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1988
Date Received
June 7, 1988
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 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)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)

FDA data resources