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

VENT-A-CAST

K Number: K843780 · Decision Nov 14, 1984
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
30
Applicant Total
2
Review Days
49

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Basic Information

Device Name
VENT-A-CAST
K Number
K843780
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.5940
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Applicant
Orthopedic Technology, Inc.
Date Received
September 26, 1984
Decision Date
November 14, 1984
Product Code
LGF
Advisory Committee
Orthopedic
Review Advisory Committee
OR
Third Party
N

Classifications

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

Product Code Device Name
LGF Component, Cast

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Other Clearances by Orthopedic Technology, Inc.

K Number Device Name
K940429 ORTHO TECH CRYOLOGIC SYSTEM