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510(k) K770162

MATERNITY SUPPORTER by R.G. Moore — Product Code FSD

K770162 is an FDA 510(k) premarket notification submitted by R.G. Moore for the device "MATERNITY SUPPORTER". The FDA issued a decision of Substantially Equivalent on February 9, 1977. The device falls under product code FSD (Binder, Abdominal), a Class I device regulated under 21 CFR 880.5160.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 9, 1977
Date Received: January 24, 1977
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Binder, Abdominal
Device Class: Class I
Regulation Number: 880.5160
Review Panel: HO
Submission Type