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510(k) K823058

DOSOMETRIC RELEASE STERILIZATION by Stan-Pak Ent. — Product Code EFQ

K823058 is an FDA 510(k) premarket notification submitted by Stan-Pak Ent. for the device "DOSOMETRIC RELEASE STERILIZATION". The FDA issued a decision of Substantially Equivalent on December 9, 1982. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Stan-Pak Ent. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1982
Date Received
October 18, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gauze/Sponge, Internal
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Stan-Pak Ent.

  • K820100 — FROSTED GLASS SLIDES (March 4, 1982)
  • K820099 — TRACH TAPE (February 23, 1982)
  • K820107 — GUAZE SPONGES, PLAIN (February 12, 1982)
  • K820106 — X-RAY GUAZE SPONGES (February 12, 1982)
  • K820155 — SPECIALIST CAST PADDING (February 12, 1982)
  • K820108 — TOPPER SPONGES (February 12, 1982)
  • K820140 — WEBRIL CAST PADDING (February 12, 1982)
  • K820142 — TUBULAR STOCKINETTE (February 5, 1982)
  • K820141 — BIAS STOCKINETTE (February 5, 1982)
  • K820056 — TELFA STRIPS (February 5, 1982)

Other clearances for product code EFQ

  • K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE (August 12, 1999)
  • K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S (June 11, 1999)
  • K990974 — VITOP DRESSING (June 9, 1999)
  • K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE (April 23, 1999)
  • K984187 — CROSSTEX NON-WOVEN SPONGES (February 18, 1999)
  • K983016 — GAUZE, SPONGES, CAT # 11-003 (February 12, 1999)
  • K983348 — DYNAREX TRACHEOSTOMY SPONGE (December 11, 1998)
  • K983450 — STARRYSHINE GAUZE SPONGE (November 12, 1998)
  • K982648 — JOAN II (September 30, 1998)
  • K980791 — DUMEX PAK-ITS WOVEN RIBBON PACKING (April 29, 1998)

FDA data resources