FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

PERFECT SUNTANNING BED

K Number: K873589 · Decision Oct 29, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
80
Applicant Total
2
Review Days
55

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Basic Information

Device Name
PERFECT SUNTANNING BED
K Number
K873589
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4635
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Wolff System Technology Corp.
Date Received
September 4, 1987
Decision Date
October 29, 1987
Product Code
LEJ
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
LEJ Booth, Sun Tan

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K Number Device Name
K151841 Ultraviolet Sunlamps