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510(k) K954455

NIOMED BOUFFANT CAPS by Amerasia Corp. — Product Code FYF

K954455 is an FDA 510(k) premarket notification submitted by Amerasia Corp. for the device "NIOMED BOUFFANT CAPS". The FDA issued a decision of Substantially Equivalent on January 23, 1996. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Amerasia Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1996
Date Received
September 25, 1995
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 Amerasia Corp.

  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954747 — NIOMED BARRIER GOWNS (March 6, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)

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)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K953878 — BOUFFANT 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)
  • K882283 — BOUFFANT CAP (June 23, 1988)

FDA data resources