The following data is part of a premarket notification filed by Savoy Medical Supply Co., Inc. with the FDA for Hospital Kit Gp 103.
Device ID | K922127 |
510k Number | K922127 |
Device Name: | HOSPITAL KIT GP 103 |
Classification | Instrument, Manual, Surgical, General Use |
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 | MDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-06 |
Decision Date | 1993-03-29 |