The following data is part of a premarket notification filed by Savoy Medical Supply Co., Inc. with the FDA for Sup 5415 Single Use Only Sterile Hospital Kit.
| Device ID | K923283 |
| 510k Number | K923283 |
| Device Name: | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT |
| Classification | Drape, Surgical |
| Applicant | SAVOY MEDICAL SUPPLY CO., INC. 745 CALEBS PATH Hauppauge, NY 11788 |
| Contact | Guy Savia |
| Correspondent | Guy Savia SAVOY MEDICAL SUPPLY CO., INC. 745 CALEBS PATH Hauppauge, NY 11788 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1993-01-04 |