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510(k) K870617

VARIOUS TYES OF SURGICAL GARMENTS by Greene International Corp. — Product Code FYF

K870617 is an FDA 510(k) premarket notification submitted by Greene International Corp. for the device "VARIOUS TYES OF SURGICAL GARMENTS". The FDA issued a decision of Substantially Equivalent on March 9, 1987. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. Greene International Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1987
Date Received
February 12, 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 Greene International Corp.

  • K883827 — MASKS, VARIOUS TYPES OF SURGICAL MASKS (November 17, 1988)
  • K883828 — CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS (October 3, 1988)
  • K880484 — SURGICAL GARMENTS (June 27, 1988)
  • K843075 — UTILITY SCISSORS DISPOSABLE ITEMS (September 5, 1984)
  • K843073 — FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP (August 24, 1984)
  • K843074 — DISPOS. & SPONGE FORCEPS PEAN ARTERY (August 17, 1984)
  • K842719 — STANDARD WHEELCHAIR (July 25, 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)
  • 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