The following data is part of a premarket notification filed by Surgical Technologies, Inc. with the FDA for Aspirating Endo Ocular Probe.
Device ID | K914247 |
510k Number | K914247 |
Device Name: | ASPIRATING ENDO OCULAR PROBE |
Classification | Source, Carrier, Fiberoptic Light |
Applicant | SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
Contact | Alan T Beckman |
Correspondent | Alan T Beckman SURGICAL TECHNOLOGIES, INC. 750 GODDARD AVE. Chesterfield, MO 63005 |
Product Code | EQH |
CFR Regulation Number | 874.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-23 |
Decision Date | 1991-12-18 |