The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept C-vac.
Device ID | K842710 |
510k Number | K842710 |
Device Name: | CONCEPT C-VAC |
Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Contact | Carl A Angles |
Correspondent | Carl A Angles CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Product Code | GCY |
CFR Regulation Number | 878.4680 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-12 |
Decision Date | 1984-10-31 |