
Procter & Gamble Mfg. Co.
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BOUNDARY HEADWEAR is an FDA 510(k)-cleared medical device (K831357) manufactured by Procter & Gamble Mfg. Co.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 1, 1983. Regulation: 8.