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510(k) K897053

L'LL SQUIRT GUM ORAL RINSE DEVICE by James R. Powell — Product Code EFS

K897053 is an FDA 510(k) premarket notification submitted by James R. Powell for the device "L'LL SQUIRT GUM ORAL RINSE DEVICE". The FDA issued a decision of Substantially Equivalent on August 6, 1990. The device falls under product code EFS (Unit, Oral Irrigation), a Class I device regulated under 21 CFR 872.6510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1990
Date Received
December 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Oral Irrigation
Device Class
Class I
Regulation Number
872.6510
Review Panel
DE
Submission Type

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FDA data resources