LATEX CONDOMS (NATURAL COLOUR)
FDA 510(k) clearance K974326 · decided 1998-02-09
Clearance details
- K-number
- K974326
- Device name
- LATEX CONDOMS (NATURAL COLOUR)
- Applicant
- Reddy Medtech Health Products , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-18
- Decision date
- 1998-02-09
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LTZ
- Device class
- 2
- Regulation number
- 884.5310
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Plainsboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.