FDA 510(k)
Substantially Equivalent
🇺🇸 United States
GLOVE LEAK DETECTOR
K Number: K901237
·
Decision Aug 21, 1990
Classifications
0
FEI Numbers
10
Registration Numbers
10
Same Product Code
80
Applicant Total
38
Review Days
159
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Basic Information
- Device Name
- GLOVE LEAK DETECTOR
- K Number
- K901237
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Utah Medical Products, Inc.
- Date Received
- March 15, 1990
- Decision Date
- August 21, 1990
- Product Code
- LDQ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- Third Party
- N
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