FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BARRIER ALL FILM
K Number: K952234
·
Decision Jul 31, 1995
Classifications
1
FEI Numbers
213
Registration Numbers
214
Same Product Code
46
Applicant Total
9
Review Days
80
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Basic Information
- Device Name
- BARRIER ALL FILM
- K Number
- K952234
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cottrell, Ltd.
- Date Received
- May 12, 1995
- Decision Date
- July 31, 1995
- Product Code
- EFS
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EFS | Unit, Oral Irrigation | FDA class 1 | Dental |
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Other Clearances by Cottrell, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K972708 | ENDO-SPOR PLUS / HYPROCIDE | Sep 13, 1999 | Substantially Equivalent |
| K970726 | VAPOCIDE | May 18, 1998 | Substantially Equivalent |
| K960089 | PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR | Apr 4, 1996 | Substantially Equivalent |
| K952241 | PROTOUCH OVERGLOVE | Aug 7, 1995 | Substantially Equivalent |
| K932922 | PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR | Jul 3, 1995 | Substantially Equivalent |
| K951983 | IMNI-II | Jun 20, 1995 | Substantially Equivalent |
| K945575 | PRO BARRIER(TM) TUBE SOX(TM) | Mar 6, 1995 | Substantially Equivalent |
| K893802 | PROVIEW SELF-SEALING STERILIZATION POUCH | Apr 4, 1990 | Substantially Equivalent |