FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
VARIOUS NON-STERILE CUSTOM TRAYS/KITS
K Number: K924690
·
Decision Jul 16, 1993
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
23
Applicant Total
1
Review Days
302
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Basic Information
- Device Name
- VARIOUS NON-STERILE CUSTOM TRAYS/KITS
- K Number
- K924690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Surgipro Central, Inc.
- Date Received
- September 17, 1992
- Decision Date
- July 16, 1993
- Product Code
- MCY
- Advisory Committee
- General Hospital
- 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 | Device Class | Medical Specialty |
|---|---|---|---|
| MCY | Wound Dressing Kit | FDA class 2 | General Hospital |
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