The following data is part of a premarket notification filed by James Consolidated, Inc. with the FDA for Dr. Volkner's Lamellar Turning Bed(tm).
| Device ID | K891457 |
| 510k Number | K891457 |
| Device Name: | DR. VOLKNER'S LAMELLAR TURNING BED(TM) |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | JAMES CONSOLIDATED, INC. P.O. BOX 3301 Walnut Creek, CA 94598 |
| Contact | Brian O James |
| Correspondent | Brian O James JAMES CONSOLIDATED, INC. P.O. BOX 3301 Walnut Creek, CA 94598 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-14 |
| Decision Date | 1989-06-20 |