FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE
K Number: K893217
·
Decision Jan 10, 1990
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
398
Applicant Total
1
Review Days
258
Basic Information
- Device Name
- LATEX PROPHYLACTIC/RUBBER CONTRACEPTIVE
- K Number
- K893217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- SHINHEN CORP.
- Date Received
- April 27, 1989
- Decision Date
- January 10, 1990
- 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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