The following data is part of a premarket notification filed by American Healthcare Supply Co., Inc. with the FDA for Premiere Sterile Suture Removal Kit(hc-50-54957).
| Device ID | K924834 |
| 510k Number | K924834 |
| Device Name: | PREMIERE STERILE SUTURE REMOVAL KIT(HC-50-54957) |
| Classification | Suture Removal Kit |
| 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 | MCZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-25 |
| Decision Date | 1993-03-23 |