FDA 510(k) K920501, SILCLAMPS DEGANIA SILICONE, by Puritas Health Care, Inc.
FDA 510(k) K920501, SILCLAMPS DEGANIA SILICONE, by Puritas Health Care, Inc.
Device Classification Name: Clamp, Vascular
510(k) Number: K920501
Device Name: SILCLAMPS DEGANIA SILICONE
Applicant: Puritas Health Care, Inc.
Regulation Number: 870.445
Classification Product Code: DXC
Date Received: 02/04/1992
Decision Date: 06/02/1992
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Cardiovascular
Total number of pages: 90
Fully redacted pages: 8
Content pages: 82
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