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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: zipe
Classification Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Product Code: MAI
Device Class: 2
Regulation Number: 888.3030
Medical Specialty: Orthopedic
Registered Establishment Name: ZIPTEK LLC
Registered Establishment Number: 3013722959
Premarket Submission Number: K162429
Owner/Operator: ZIPTEK LLC
Owner/Operator Number: 10055345
Establishment Operations: Specification Developer
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