The following data is part of a premarket notification filed by Teledyne Water Pik with the FDA for Elastic Impression Cream.
Device ID | K952422 |
510k Number | K952422 |
Device Name: | ELASTIC IMPRESSION CREAM |
Classification | Material, Impression |
Applicant | TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
Contact | Cody Riley |
Correspondent | Cody Riley TELEDYNE WATER PIK 1730 EAST PROSPECT RD. Fort Collins, CO 80525 -1310 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-23 |
Decision Date | 1995-08-29 |