The following data is part of a premarket notification filed by American Healthcare Supply Co., Inc. with the FDA for Shave Prep Trays (non-sterile).
| Device ID | K925214 |
| 510k Number | K925214 |
| Device Name: | SHAVE PREP TRAYS (NON-STERILE) |
| Classification | General Surgery Tray |
| Applicant | AMERICAN HEALTHCARE SUPPLY CO., INC. 6 INGERSOLL RD. P.O. BOX 544 South Plainfield, NJ 07080 |
| Contact | Ralph S Jarrett |
| Correspondent | Ralph S Jarrett AMERICAN HEALTHCARE SUPPLY CO., INC. 6 INGERSOLL RD. P.O. BOX 544 South Plainfield, NJ 07080 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-16 |
| Decision Date | 1993-07-02 |