FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
STERILE CENTRAL LINE DRESSING TRAY
K Number: K934031
·
Decision Mar 1, 1994
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
5
Review Days
196
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Basic Information
- Device Name
- STERILE CENTRAL LINE DRESSING TRAY
- K Number
- K934031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Surgipro, Inc.
- Date Received
- August 17, 1993
- Decision Date
- March 1, 1994
- Product Code
- FRG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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