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ISC-1000 PENTAX CONFOCAL LASER SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K042740
510(k) Type
Traditional
Applicant
PENTAX MEDICAL COMPANY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/19/2004
Days to Decision
15 days
Submission Type
Summary

ISC-1000 PENTAX CONFOCAL LASER SYSTEM

Page Type
Cleared 510(K)
510(k) Number
K042740
510(k) Type
Traditional
Applicant
PENTAX MEDICAL COMPANY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/19/2004
Days to Decision
15 days
Submission Type
Summary