MITRAFLEX WOUND DRESSING WET-STICK— 510(k) K952217

Clearance details

Applicant

Polymedica Industries, Inc.

Product code

Code MGP

Device class

Unclassified

Advisory panel

Unknown

Date received

1995-05-11

Decision date

1995-06-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Golden,, CO, US

• K012995 — COLLATEK SHEET2001-10-25
• K012997 — COLLATEK FOAM2001-10-25
• K001508 — LASERSKIN DRESSING2001-07-25
• K990079 — FASTSEAL CHEST WOUND DRESSING1999-12-23
• K991214 — SIMPLICARE TRANSPARENT WOUND DRESSING1999-10-14

• K964398 — SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED1997-10-24
• K971045 — BASIS FLEXIBLE TIP DIGITAL THERMOMETER1997-05-02
• K964701 — MITRAFLEX PIGMENTED WOUND DRESSING1997-02-07
• K963623 — SPYROFLEX PIGMENTED WOUND DRESSING1996-10-25
• K962991 — BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER1996-09-12

Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →