The following data is part of a premarket notification filed by Metro Medical Equipment, Inc. with the FDA for Hec 1000.
Device ID | K020466 |
510k Number | K020466 |
Device Name: | HEC 1000 |
Classification | Chamber, Oxygen, Topical, Extremity |
Applicant | METRO MEDICAL EQUIPMENT, INC. 12985 WAYNE RD. Livonia, MI 48150 |
Contact | Paul Mocur |
Correspondent | Paul Mocur METRO MEDICAL EQUIPMENT, INC. 12985 WAYNE RD. Livonia, MI 48150 |
Product Code | KPJ |
CFR Regulation Number | 878.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-12 |
Decision Date | 2002-05-08 |
Summary: | summary |