The following data is part of a premarket notification filed by Northland Dental Engineering with the FDA for Sbp Dental Unit.
Device ID | K934436 |
510k Number | K934436 |
Device Name: | SBP DENTAL UNIT |
Classification | Unit, Operative Dental |
Applicant | NORTHLAND DENTAL ENGINEERING BOX 150-A Ridgeland, WI 54763 |
Contact | Dewayne Varnes |
Correspondent | Dewayne Varnes NORTHLAND DENTAL ENGINEERING BOX 150-A Ridgeland, WI 54763 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-23 |
Decision Date | 1994-06-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00736239100081 | K934436 | 000 |