The following data is part of a premarket notification filed by The South India Surgical Co. Pvt. Ltd. with the FDA for Forceps, Surgical, Gynecological.
Device ID | K892820 |
510k Number | K892820 |
Device Name: | FORCEPS, SURGICAL, GYNECOLOGICAL |
Classification | Forceps, Surgical, Gynecological |
Applicant | THE SOUTH INDIA SURGICAL CO. PVT. LTD. 850 MOUNT ROAD MADRAS-600 002 India, IN |
Contact | Vivek Bajaj |
Correspondent | Vivek Bajaj THE SOUTH INDIA SURGICAL CO. PVT. LTD. 850 MOUNT ROAD MADRAS-600 002 India, IN |
Product Code | HCZ |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-11 |
Decision Date | 1989-06-22 |