The following data is part of a premarket notification filed by L & M Resource Information Service, Inc. with the FDA for Standard Wheelchair.
| Device ID | K963301 |
| 510k Number | K963301 |
| Device Name: | STANDARD WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | L & M RESOURCE INFORMATION SERVICE, INC. 1860 N.E. 124TH ST. Miami, FL 33166 |
| Contact | Manuel J Aguirre |
| Correspondent | Manuel J Aguirre L & M RESOURCE INFORMATION SERVICE, INC. 1860 N.E. 124TH ST. Miami, FL 33166 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-21 |
| Decision Date | 1996-10-23 |