The following data is part of a premarket notification filed by Great West Medical Equipment, Inc. with the FDA for Home Medical Kit - For Little Hurts.
| Device ID | K912684 |
| 510k Number | K912684 |
| Device Name: | HOME MEDICAL KIT - FOR LITTLE HURTS |
| Classification | Wound Dressing Kit |
| Applicant | GREAT WEST MEDICAL EQUIPMENT, INC. 2081 ESQUIMALT AVENUE West Vancouver, B.c., CA V7v 1s3 |
| Contact | Mason C Kent |
| Correspondent | Mason C Kent GREAT WEST MEDICAL EQUIPMENT, INC. 2081 ESQUIMALT AVENUE West Vancouver, B.c., CA V7v 1s3 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-14 |
| Decision Date | 1991-10-15 |