The following data is part of a premarket notification filed by Mcvicar Enterprises, Ltd. with the FDA for The Waverly Wedge(tm) Inflatable Air Cushion.
| Device ID | K895444 |
| 510k Number | K895444 |
| Device Name: | THE WAVERLY WEDGE(TM) INFLATABLE AIR CUSHION |
| Classification | Table, Mechanical |
| Applicant | MCVICAR ENTERPRISES, LTD. 461 LINDEN PLACE, B.C. VOR 2T0, BOX 878 Qualicum Beach, CA |
| Contact | Diarmid Mcvicar |
| Correspondent | Diarmid Mcvicar MCVICAR ENTERPRISES, LTD. 461 LINDEN PLACE, B.C. VOR 2T0, BOX 878 Qualicum Beach, CA |
| Product Code | INW |
| CFR Regulation Number | 890.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-05 |
| Decision Date | 1989-12-13 |