FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT
K Number: K901147
·
Decision Nov 30, 1990
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
179
Applicant Total
2
Review Days
263
Basic Information
- Device Name
- JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT
- K Number
- K901147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- JOSLYN VALVE CORP.
- Date Received
- March 12, 1990
- Decision Date
- November 30, 1990
- Product Code
- FLE
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by JOSLYN VALVE CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K901146 | JOSLYN EO STERILIZER/ EO MODERNIZATION KIT | Mar 7, 1991 | Substantially Equivalent |