
The Anspach Effort, Inc.
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CRANIAL PERFORATOR is an FDA 510(k)-cleared medical device (K082637) manufactured by The Anspach Effort, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 21, 2008. Regulation: 8.