Atlas FDA

UNI-SITE

FDA 510(k) clearance K953018 · decided 1995-09-08

Clearance details

K-number
K953018
Device name
UNI-SITE
Applicant
Ttl Medical
Decision
Substantially Equivalent
Date received
1995-06-29
Decision date
1995-09-08
Days to decision
71 days
Clearance type
Traditional
Product code
MGP
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Knoxville, TN, US
Third-party review
No
Expedited review
No

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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.