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ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972836
510(k) Type
Traditional
Applicant
G. PREMJEE (USA), INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/22/1997
Days to Decision
83 days
Submission Type
Summary

ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K972836
510(k) Type
Traditional
Applicant
G. PREMJEE (USA), INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/22/1997
Days to Decision
83 days
Submission Type
Summary