The following data is part of a premarket notification filed by Preferred Medical Products with the FDA for Spinal Anesthesia Tray.
Device ID | K885277 |
510k Number | K885277 |
Device Name: | SPINAL ANESTHESIA TRAY |
Classification | Anesthesia Conduction Kit |
Applicant | PREFERRED MEDICAL PRODUCTS 100 WEST BEAVER CREEK RD.UNIT 21,ONT. Richmond Hill L4b1h4, CA |
Contact | John Roschuk |
Correspondent | John Roschuk PREFERRED MEDICAL PRODUCTS 100 WEST BEAVER CREEK RD.UNIT 21,ONT. Richmond Hill L4b1h4, CA |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-23 |
Decision Date | 1989-03-06 |