HEATCASE(TM)

FDA Premarket Approval P830001 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceHEATCASE(TM)
Generic NameSterilizer, Soft-lens, Thermal, Ac-powered
ApplicantWESLEY JESSEN CORP.
Date Received1983-11-14
Decision Date1984-11-30
PMAP830001
SupplementS001
Product CodeHRD 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610

Supplemental Filings

Supplement NumberDateSupplement Type
P830001Original Filing
S002 1983-12-09
S001 1983-11-14

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