FDA 510(k)

PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS

K-Number: K012804 · 2002-01-17

Decision Date2002-01-17

Product CodeMVA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Scott E Allen CP. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K012804. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS?

PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Scott E Allen CP. The 510(k) number is K012804.

When did PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS receive FDA 510(k) clearance?

PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS received FDA 510(k) clearance on 2002-01-17, under 510(k) number K012804.

Who is the listed applicant for PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS?

The FDA 510(k) record lists Scott E Allen CP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS?

The FDA product code for PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS is MVA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.