FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASSURE, SELF-SEALING STERILIZATION POUCH
K Number: K951590
·
Decision May 17, 1995
Classifications
1
FEI Numbers
265
Registration Numbers
265
Same Product Code
270
Applicant Total
11
Review Days
41
Basic Information
- Device Name
- ASSURE, SELF-SEALING STERILIZATION POUCH
- K Number
- K951590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SULTAN CHEMISTS, INC.
- Date Received
- April 6, 1995
- Decision Date
- May 17, 1995
- Product Code
- KCT
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
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| K Number | Device Name | ||
|---|---|---|---|
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| K043054 | GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL | Feb 18, 2005 | Substantially Equivalent |
| K030414 | GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL | Apr 9, 2003 | Substantially Equivalent |
| K020612 | SULTAN SPOROX TEST VIAL, MODEL 75195 | May 7, 2002 | Substantially Equivalent |
| K002843 | SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010 | Nov 15, 2000 | Substantially Equivalent |
| K991509 | PRO-PORTION CLEANER/DISINFECTANT | Jul 14, 1999 | Substantially Equivalent |
| K971138 | DINABASE (TM) | Jul 21, 1997 | Substantially Equivalent |
| K933729 | ASSURE SELF SEALING STERILIZATION POUCH | Jun 21, 1994 | Substantially Equivalent |
| K896826 | SULTAN PERIO-SELECT IRRIGATION SYSTEM | Mar 2, 1990 | Unknown |