
Custom Sterile Services, Inc.
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REUSABLE TOWEL AND GOWN PACKS is an FDA 510(k)-cleared medical device (K930167) manufactured by Custom Sterile Services, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 1993. Regulation: 8.