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510(k) K874066

SURGICAL CAPS by Interpro Intl., Inc. — Product Code FYF

K874066 is an FDA 510(k) premarket notification submitted by Interpro Intl., Inc. for the device "SURGICAL CAPS". The FDA issued a decision of Substantially Equivalent on November 4, 1987. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Interpro Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1987
Date Received
October 5, 1987
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 Interpro Intl., Inc.

  • K890968 — VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) (July 31, 1989)
  • K891642 — PATIENT EXAMINATION GLOVES (LATEX) (July 14, 1989)
  • K890891 — LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) (July 14, 1989)
  • K891440 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K891438 — PATIENT EXAMINATION GLOVES (LATEX) (May 31, 1989)
  • K881374 — SURGEONS GLOVES (August 5, 1988)
  • K874067 — GUAZE SPONGES (December 14, 1987)
  • K874766 — INTERPRO INT'L, INC. ISOLATION GOWN (December 10, 1987)
  • K874065 — LAPAROTOMY SPONGES (November 4, 1987)
  • K874064 — SHOE COVERS (November 4, 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)
  • 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