FDA 510(k) FDA not classified Substantially Equivalent 🇺🇸 United States

FIRST AID SURVIVAL KIT

K Number: K891483 · Decision May 11, 1989
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
14
Applicant Total
2
Review Days
55

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Basic Information

Device Name
FIRST AID SURVIVAL KIT
K Number
K891483
Device Class
FDA not classified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Elwyn, Inc.
Date Received
March 17, 1989
Decision Date
May 11, 1989
Product Code
LRR
Advisory Committee
Unknown
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
LRR First Aid Kit With Drug

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Other Clearances by Elwyn, Inc.

K Number Device Name
K891133 VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS