The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Resubmitted Water Purifier For Use W/dental Treat.
Device ID | K901672 |
510k Number | K901672 |
Device Name: | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT |
Classification | Unit, Operative Dental |
Applicant | PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
Contact | James R Grieger |
Correspondent | James R Grieger PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-10 |
Decision Date | 1990-07-06 |