The following data is part of a premarket notification filed by Emergency Products And Research with the FDA for Pedi-spider Strap.
Device ID | K061721 |
510k Number | K061721 |
Device Name: | PEDI-SPIDER STRAP |
Classification | Stretcher, Patient Restraint |
Applicant | EMERGENCY PRODUCTS AND RESEARCH 890 WEST MAIN STREET Kent, OH 44240 |
Contact | Mark Moehler |
Correspondent | Mark Moehler EMERGENCY PRODUCTS AND RESEARCH 890 WEST MAIN STREET Kent, OH 44240 |
Product Code | NZD |
CFR Regulation Number | 880.6900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-19 |
Decision Date | 2006-08-17 |
Summary: | summary |