FDA 510(k)
Substantially Equivalent
🇺🇸 United States
FLUORESOFT
K Number: K780125
·
Decision Mar 15, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
1
Review Days
50
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Basic Information
- Device Name
- FLUORESOFT
- K Number
- K780125
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Holles Laboratories, Inc.
- Date Received
- January 24, 1978
- Decision Date
- March 15, 1978
- Product Code
- KYC
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- Third Party
- N
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