FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

HOSPITAL KIT DK 117

K Number: K922130 · Decision May 24, 1993
Classifications
1
FEI Numbers
840
Registration Numbers
840
Same Product Code
43
Applicant Total
7
Review Days
383

Basic Information

Device Name
HOSPITAL KIT DK 117
K Number
K922130
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4800
Medical Specialty
General, Plastic Surgery
Decision
Unknown
Statement or Summary
Statement
Applicant
SAVOY MEDICAL SUPPLY CO., INC.
Date Received
May 6, 1992
Decision Date
May 24, 1993
Product Code
MDM
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
MDM Instrument, Manual, Surgical, General Use

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K Number Device Name
K922133 HOSPITAL KIT SV 105
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K922128 HOSPITAL KIT EP 104
K922126 HOSPITAL KIT ENT 1125
K923283 SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT