510(k) K981621
- Device
- ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
- Applicant
- SURETEX PROPHYLACTICS (INDIA) LTD.
- 510(k) number
- K981621
- Product code
- LTZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-06-19
- Date received
- 1998-05-06
- Regulation
- 884.5310
- Classification name
- Condom With Nonoxynol-9
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- V V RAMANA RAO
- Address
- 74-91 Kiadb Industrial Estate Jigani Ii Phase,Anekal Taluk Bangalore, Karnataka IN 562106 562106
FDA Registration Numbers#
- 3003592318
- 3013770781
- 3008808138
- 9613994
- 3003491851
- 3003759643
- 9613932
- 3021234378
- 2280705
- 8040641
- 1000136042
- 1122329
Source Documents#
Legacy Summary#
summary
FDA Review#
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