The following data is part of a premarket notification filed by Novare Surgical Systems, Inc. with the FDA for Realhand High Dexterity Instruments.
Device ID | K072715 |
510k Number | K072715 |
Device Name: | REALHAND HIGH DEXTERITY INSTRUMENTS |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | NOVARE SURGICAL SYSTEMS, INC. 1070 CONCORD AVE., SUITE 230 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf NOVARE SURGICAL SYSTEMS, INC. 1070 CONCORD AVE., SUITE 230 Concord, CA 94520 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-25 |
Decision Date | 2007-10-16 |
Summary: | summary |