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510(k) K821701

RAPIDO-LASTIC IN STERILE FORM by Conco Medical Co. — Product Code EFQ

K821701 is an FDA 510(k) premarket notification submitted by Conco Medical Co. for the device "RAPIDO-LASTIC IN STERILE FORM". The FDA issued a decision of Substantially Equivalent on July 22, 1982. The device falls under product code EFQ (Gauze/Sponge, Internal), a Class U device. Conco Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1982
Date Received
June 8, 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 Conco Medical Co.

  • K904819 — SHUR-LOCK ICE WRAP SYSTEM (December 6, 1990)
  • K820826 — STAX FINGER SPLINT (April 8, 1982)
  • K820381 — FINGER PROTECTOR (March 1, 1982)
  • K820380 — CURVED FINGER SPLINT (March 1, 1982)
  • K820382 — FROG SPLINT (March 1, 1982)
  • K820383 — FINGER COT (February 24, 1982)
  • K760141 — BANDAGE, CONFO-LASTIC ALL COTTON ELASTIC (July 19, 1976)
  • K760140 — BANDAGE, WRINKY-LASTIC ELASTIC GAUZE (July 19, 1976)
  • K760142 — BANDAGE, RAPIDO-LASTIC COTTON/NYLON (July 19, 1976)
  • K760139 — BANDAGE, E-COTTON ELASTIC (July 19, 1976)

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