The following data is part of a premarket notification filed by Ovamed Corp. with the FDA for Saratoga Modular Miniature Endoscope System.
Device ID | K943593 |
510k Number | K943593 |
Device Name: | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM |
Classification | Mini Endoscope, Gastroenterology-urology |
Applicant | OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
Contact | John Zink |
Correspondent | John Zink OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
Product Code | ODF |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-25 |
Decision Date | 1995-03-22 |