FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIACIDE HD DISINFECTING SOLUTION
K Number: K944037
·
Decision Mar 22, 1995
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
72
Applicant Total
2
Review Days
216
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Basic Information
- Device Name
- DIACIDE HD DISINFECTING SOLUTION
- K Number
- K944037
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gulfstream Medical
- Date Received
- August 18, 1994
- Decision Date
- March 22, 1995
- Product Code
- LRJ
- 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 |
|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | FDA class 1 | General Hospital |
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Other Clearances by Gulfstream Medical
| K Number | Device Name | ||
|---|---|---|---|
| K951214 | STERILE EQUIPMENT COVER | May 16, 1995 | Substantially Equivalent |