The following data is part of a premarket notification filed by Belmont Equipment Corp. with the FDA for Belmont Unit, Model 2000 Series.
Device ID | K000799 |
510k Number | K000799 |
Device Name: | BELMONT UNIT, MODEL 2000 SERIES |
Classification | Unit, Operative Dental |
Applicant | BELMONT EQUIPMENT CORP. 101 BELMONT DR. Somerset, NJ 08873 -1204 |
Contact | John E Collins |
Correspondent | John E Collins BELMONT EQUIPMENT CORP. 101 BELMONT DR. Somerset, NJ 08873 -1204 |
Product Code | EIA |
CFR Regulation Number | 872.6640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-13 |
Decision Date | 2000-05-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04952195217403 | K000799 | 000 |
04952195414512 | K000799 | 000 |
04952195414529 | K000799 | 000 |
04952195414536 | K000799 | 000 |
04952195393558 | K000799 | 000 |
04952195393572 | K000799 | 000 |
04952195383276 | K000799 | 000 |
04952195383283 | K000799 | 000 |
04952195383313 | K000799 | 000 |
04952195217311 | K000799 | 000 |
04952195217328 | K000799 | 000 |
04952195217335 | K000799 | 000 |
04952195217342 | K000799 | 000 |
04952195217359 | K000799 | 000 |
04952195217366 | K000799 | 000 |
04952195217373 | K000799 | 000 |
04952195217380 | K000799 | 000 |
04952195217397 | K000799 | 000 |
04952195414505 | K000799 | 000 |