FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

DOW CORNING/W RIGHT WOUND DRAINAGE SYS

K Number: K800014 · Decision Jan 17, 1980
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
31
Review Days
13

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Basic Information

Device Name
DOW CORNING/W RIGHT WOUND DRAINAGE SYS
K Number
K800014
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4680
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Dow Corning Corp. Healthcare Industries Materials
Date Received
January 4, 1980
Decision Date
January 17, 1980
Product Code
GCY
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

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K843995 TF-II HIP PROSTHESIS
K842559 WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K840357 SSA HIP PROSTHESIS
K831479 METAL-BACKED ACETABULAR CUP
K812864 SILASTIC VOICE PROSTHESIS
K812053 SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)
K811679 SILASTIC TENDON PASSER H.P.
Search all 31 clearances from Dow Corning Corp. Healthcare Industries Materials →