The following data is part of a premarket notification filed by Apex Medical, Inc. with the FDA for Eliminator Air Filter.
Device ID | K882468 |
510k Number | K882468 |
Device Name: | ELIMINATOR AIR FILTER |
Classification | Bottle, Collection, Vacuum |
Applicant | APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
Contact | Larry Inman |
Correspondent | Larry Inman APEX MEDICAL, INC. 990 DILLMAN RD. Martinsville, IN 46151 |
Product Code | KDQ |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-15 |
Decision Date | 1988-08-29 |