The following data is part of a premarket notification filed by Joerns Healthcare, Inc. with the FDA for Joerns Healthcare, Inc. Full Length Telescoping Rail.
| Device ID | K951735 |
| 510k Number | K951735 |
| Device Name: | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL |
| Classification | Bed, Ac-powered Adjustable Hospital |
| Applicant | JOERNS HEALTHCARE, INC. 5001 JOERNS DR. Stevens Point, WI 54481 -5040 |
| Contact | Mark Grace |
| Correspondent | Mark Grace JOERNS HEALTHCARE, INC. 5001 JOERNS DR. Stevens Point, WI 54481 -5040 |
| Product Code | FNL |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-14 |
| Decision Date | 1995-08-18 |