The following data is part of a premarket notification filed by Savoy Medical Supply Co., Inc. with the FDA for Hospital Kit Ent 1125.
| Device ID | K922126 |
| 510k Number | K922126 |
| Device Name: | HOSPITAL KIT ENT 1125 |
| Classification | Tray, Surgical |
| Applicant | SAVOY MEDICAL SUPPLY CO., INC. 99 W. HAWTHORNE AVE. Valley Stream, NY 11580 |
| Contact | Guy Savia |
| Correspondent | Guy Savia SAVOY MEDICAL SUPPLY CO., INC. 99 W. HAWTHORNE AVE. Valley Stream, NY 11580 |
| Product Code | LRP |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-06 |
| Decision Date | 1993-01-21 |