The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Pressure Sore Management Kit.
| Device ID | K912116 |
| 510k Number | K912116 |
| Device Name: | PRESSURE SORE MANAGEMENT KIT |
| Classification | Wound Dressing Kit |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | MCY |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-10-18 |