ALOCLAIR ORAL RINSE


Device Classification Name

dressing, wound and burn, hydrogel w/drug and/or biologic

510(k) Number K023155
Device Name ALOCLAIR ORAL RINSE
Original Applicant
SINCLAIR PHARMACEUTICALS, LTD.
borough rd.
godalming, surrey, 

GB

gu7 2ab

Original Contact denise swift
Classification Product Code
MGQ  
Date Received 09/23/2002
Decision Date 11/25/2002
Decision

substantially equivalent

(SESE)

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No