
Spectrum/Hydro-Med Products, Inc.
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STERILE ESMARCH BANDAGE is an FDA 510(k)-cleared medical device (K881176) manufactured by Spectrum/Hydro-Med Products, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 10, 1988. Regulation: 8.