Cleared Traditional

SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

K991215 · Symtex Healthcare Corp. · General & Plastic Surgery

Jun 1999

Decision

63d

Days

—

Risk

About This 510(k) Submission

K991215 is an FDA 510(k) clearance for the SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S, a Gauze/sponge, Internal, submitted by Symtex Healthcare Corp. (Walnut, US). The FDA issued a Cleared decision on June 11, 1999, 63 days after receiving the submission on April 9, 1999. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K991215 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 1999
Decision Date	June 11, 1999
Days to Decision	63 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement