Home / 510(k) Clearances / K833867

510(k) K833867

PAREMA K BAND NON-STERILE by Mark One Healthcare Products — Product Code EFQ

K833867 is an FDA 510(k) premarket notification submitted by Mark One Healthcare Products for the device "PAREMA K BAND NON-STERILE". The FDA issued a decision of Substantially Equivalent on January 27, 1984. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Mark One Healthcare Products has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1984
Date Received
November 7, 1983
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 Mark One Healthcare Products

  • K891986 — MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE (December 29, 1989)
  • K833084 — MASTERHINGE (October 14, 1983)
  • K770396 — DRAPES, MODESTY (March 23, 1977)
  • K761268 — SKIN PRESSURE PROTECTORS (February 16, 1977)

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