FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
SAFE.N.SURE
K Number: K852620
·
Decision Oct 31, 1985
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
12
Review Days
133
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Basic Information
- Device Name
- SAFE.N.SURE
- K Number
- K852620
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Ashai Co. , Ltd.
- Date Received
- June 20, 1985
- Decision Date
- October 31, 1985
- Product Code
- HIS
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Ashai Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K870428 | AEROSOL ONE, NEBULIZER PUMP | May 15, 1987 | Substantially Equivalent |
| K852622 | AEROSOL ONE | Apr 24, 1986 | Substantially Equivalent |
| K852627 | MAXI-NEB | Sep 26, 1985 | Substantially Equivalent |
| K852628 | NASAL ONE | Sep 18, 1985 | Substantially Equivalent |
| K852625 | OXY-TUBE | Sep 18, 1985 | Substantially Equivalent |
| K852629 | AERO-MASK TWO | Sep 18, 1985 | Substantially Equivalent |
| K852624 | OXY-TWO | Sep 18, 1985 | Substantially Equivalent |
| K852618 | OXY-DIAL | Sep 18, 1985 | Substantially Equivalent |
| K852626 | AERO-MASK ONE | Sep 18, 1985 | Substantially Equivalent |
| K852623 | OXY-ONE | Sep 18, 1985 | Substantially Equivalent |