The following data is part of a premarket notification filed by Ellman Intl., Inc. with the FDA for Surgitron Model Ffpf-emc.
Device ID | K972072 |
510k Number | K972072 |
Device Name: | SURGITRON MODEL FFPF-EMC |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett, NY 11557 |
Contact | Frank Lin |
Correspondent | Frank Lin ELLMAN INTL., INC. 1135 RAILROAD AVE., ELLMAN BLDG. Hewlett, NY 11557 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-06-03 |
Decision Date | 1997-06-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841494104900 | K972072 | 000 |
00841494104894 | K972072 | 000 |