DUKAL ABD COMBINE PAD— 510(k) K970457

Clearance details

Applicant

Dukal Corp.

Product code

Code EFQ

Device class

Unclassified

Advisory panel

Unknown

Date received

1997-02-06

Decision date

1997-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tarpon Springs, FL, US

• K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
• K991215 — SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S1999-06-11
• K990974 — VITOP DRESSING1999-06-09
• K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
• K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

• K083320 — DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE2009-03-06
• K070407 — DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE2007-03-26
• K061864 — DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 15602006-09-15
• K020726 — DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE2002-05-15
• K984564 — ETHYL CHLORIDE DISPENSER1999-12-02