FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRO-PORTION CLEANER/DISINFECTANT
K Number: K991509
·
Decision Jul 14, 1999
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
72
Applicant Total
11
Review Days
75
Basic Information
- Device Name
- PRO-PORTION CLEANER/DISINFECTANT
- K Number
- K991509
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SULTAN CHEMISTS, INC.
- Date Received
- April 30, 1999
- Decision Date
- July 14, 1999
- 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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| K971138 | DINABASE (TM) | Jul 21, 1997 | Substantially Equivalent |
| K951590 | ASSURE, SELF-SEALING STERILIZATION POUCH | May 17, 1995 | Substantially Equivalent |
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