Atlas FDA

3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES

FDA 510(k) clearance K973036 · decided 1997-11-12

Clearance details

K-number
K973036
Device name
3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES
Applicant
3M Healthcare
Decision
Substantially Equivalent for Some Indications
Date received
1997-08-14
Decision date
1997-11-12
Days to decision
90 days
Clearance type
Traditional
Product code
MGP
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch 3M Healthcare

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
COLLATEK SHEET (K012995)Biocore Medical Technologies, Inc.2001-10-25
COLLATEK FOAM (K012997)Biocore Medical Technologies, Inc.2001-10-25
LASERSKIN DRESSING (K001508)Fidia Advanced Biopolymers Srl2001-07-25
FASTSEAL CHEST WOUND DRESSING (K990079)Greenfield Medical Technologies, Inc.1999-12-23
SIMPLICARE TRANSPARENT WOUND DRESSING (K991214)Hollister, Inc.1999-10-14
DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS (K992302)Dermaphylyx, Inc.1999-09-14
GILTECH PLUS TRANSPARENT DRESSING (K992005)Giltech Plus, Inc.1999-09-03
DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING (K990875)Dermaphylyx, Inc.1999-05-27
DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING (K990438)Dermaphylyx, Inc.1999-03-25
MEPITEL NON ADHERENT SILICONE DRESSING (K984371)Molnlycke Health Care, Inc.1999-03-03
INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS (K983303)Innovative Technologies , Ltd.1998-12-09
TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING (K983234)Johnson & Johnson Medical, Div. of Ethicon, Inc.1998-11-25

Recalls involving this device

No recalls on record reference this clearance.