
Custom Services Intl., Inc.
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INNERWEAR/EXTRAWEAR/JIMMY-O RAINCOAT/ZEUS/GENTLEMEN'S CHOICE/JASMINE/DRINK/NAUGHTY is an FDA 510(k)-cleared medical device (K970791) manufactured by Custom Services Intl., Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 1997. Regulation: 8.

Ansell
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McKesson
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Hollister
SKU VM-1270031