FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
K Number: K983320
·
Decision Dec 11, 1998
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
3
Review Days
81
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Basic Information
- Device Name
- ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
- K Number
- K983320
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Suretex Prophylactics (India) , Ltd.
- Date Received
- September 21, 1998
- Decision Date
- December 11, 1998
- 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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