510(k) K971132
K971132 is an FDA 510(k) premarket notification submitted by G. Premjee (Usa), Inc. for the device "ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS". The FDA issued a decision of Substantially Equivalent on September 3, 1997. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. G. Premjee (Usa), Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 1997
- Date Received
- March 27, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type