510(k) K952422

ELASTIC IMPRESSION CREAM by Teledyne Water Pik — Product Code ELW

K952422 is an FDA 510(k) premarket notification submitted by Teledyne Water Pik for the device "ELASTIC IMPRESSION CREAM". The FDA issued a decision of Substantially Equivalent on August 29, 1995. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Teledyne Water Pik has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1995
Date Received
May 23, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
Review Panel
DE
Submission Type