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FDA 510(k) Applications Submitted by G. PREMJEE (USA), INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K971132
03/27/1997
ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS
G. PREMJEE (USA), INC.
K972836
07/31/1997
ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS
G. PREMJEE (USA), INC.
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