The following data is part of a premarket notification filed by Commercial Products & Engineering Co. with the FDA for Portable Field Dental Operating & Treatment Unit.
Device ID | K873545 |
510k Number | K873545 |
Device Name: | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT |
Classification | Evacuator, Oral Cavity |
Applicant | COMMERCIAL PRODUCTS & ENGINEERING CO. 5001 KENDRICK, S.E. Grand Rapids, MI 49512 |
Contact | John Lomonaco |
Correspondent | John Lomonaco COMMERCIAL PRODUCTS & ENGINEERING CO. 5001 KENDRICK, S.E. Grand Rapids, MI 49512 |
Product Code | EHZ |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-01 |
Decision Date | 1987-11-20 |