The following data is part of a premarket notification filed by Nexus Health Care Products Ltd. with the FDA for Evacu Sled.
Device ID | K913520 |
510k Number | K913520 |
Device Name: | EVACU SLED |
Classification | Stretcher, Hand-carried |
Applicant | NEXUS HEALTH CARE PRODUCTS LTD. 160 JAMES STREET EAST Cobourg, Ontario, CA K9a 1h3 |
Contact | Jeffrey Sparling |
Correspondent | Jeffrey Sparling NEXUS HEALTH CARE PRODUCTS LTD. 160 JAMES STREET EAST Cobourg, Ontario, CA K9a 1h3 |
Product Code | FPP |
CFR Regulation Number | 880.6900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-07 |
Decision Date | 1991-12-04 |