The following data is part of a premarket notification filed by Greenleaf Medical Systems, Inc. with the FDA for Greenleaf Hand Impairment Evaluation System.
| Device ID | K893537 |
| 510k Number | K893537 |
| Device Name: | GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM |
| Classification | Dynamometer, Ac-powered |
| Applicant | GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto, CA 94306 |
| Contact | Kimberly Crocker |
| Correspondent | Kimberly Crocker GREENLEAF MEDICAL SYSTEMS, INC. 2248 PARK BLVD. Palo Alto, CA 94306 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-08 |
| Decision Date | 1989-10-10 |