FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRO-TECH
K Number: K955850
·
Decision Feb 9, 1996
Classifications
1
FEI Numbers
370
Registration Numbers
370
Same Product Code
72
Applicant Total
7
Review Days
44
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Basic Information
- Device Name
- PRO-TECH
- K Number
- K955850
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Central Solutions, Inc.
- Date Received
- December 27, 1995
- Decision Date
- February 9, 1996
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRJ), ordered by most recent decision date.
CONTROL III ELITE
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AMERSE 2
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DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
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LOW PH PHENOLIC 256
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Central Solutions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983585 | LOW PH PHENOLIC 256 | Nov 6, 1998 | Substantially Equivalent |
| K954292 | Q5. 5-5.5NPB-2.5HW | Sep 27, 1995 | Substantially Equivalent |
| K951020 | TRI-CEN GERMICIDAL DETERGENT | Aug 28, 1995 | Substantially Equivalent |
| K951162 | PHENO-CEN GERMICIDAL DETERGENT | Jul 11, 1995 | Substantially Equivalent |
| K951342 | Q4.5-5.0PB-4.5 | Apr 25, 1995 | Substantially Equivalent |
| K951317 | PHENO-CEN SPRAY DISINFECTANT DEODORANT | Apr 25, 1995 | Substantially Equivalent |