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

SDC VASCULAR TIES

K Number: K833355 · Decision Jan 27, 1984
Classifications
1
FEI Numbers
231
Registration Numbers
231
Same Product Code
66
Applicant Total
9
Review Days
121

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Basic Information

Device Name
SDC VASCULAR TIES
K Number
K833355
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Science Development Corp.
Date Received
September 28, 1983
Decision Date
January 27, 1984
Product Code
KDC
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
KDC Instrument, Surgical, Disposable

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Other Clearances by Science Development Corp.

K Number Device Name
K843617 SDC SILICONE SUMP DRAIN
K842491 SDC SILICONE FORCEP SHODS PRODUCT
K832090 SCD SKIN TEMP. SENSORS #3400 ETC
K832391 QT-100 ELECTRONIC TEMP. MONITOR
K832392 SDC ORAL-RECTAL TEMP. PROBE
K830353 ESOPHAGEAL PROBE W/TEMP. INDICATOR
K830329 ESOPHAGEAL STETHOSCOPE
K830039 SDC RECTAL TEMP. PROBE PRODUCT #1020