FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESUBMITTED STC SERIES 8600 AUTOCLAVE
K Number: K890359
·
Decision Aug 7, 1989
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
2
Review Days
194
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Basic Information
- Device Name
- RESUBMITTED STC SERIES 8600 AUTOCLAVE
- K Number
- K890359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Sterilizer Technologies Corp.
- Date Received
- January 25, 1989
- Decision Date
- August 7, 1989
- 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 Sterilizer Technologies Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K904112 | STI DRAPE SHEET STYLE 1908 | Oct 30, 1990 | Substantially Equivalent |