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X-Ray Attenuating Cream

by Bloxr Corporation De Novo

Active United States

De Novo DEN120022

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN120022 Date9 May 2013DecidedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 9 Oct 2026.

Specification

De Novo

De Novo Number
FDA Product Code
PDK
Device Class
Class II
Regulation
21 CFR Part 892.6510
Advisory Committee
Radiology
FDA Decision
DENG De Novo granted

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