The following data is part of a premarket notification filed by Tahoe Surgical Instruments P.r., Inc. with the FDA for Tahoe Surgical Instruments Ligature Device.
Device ID | K941944 |
510k Number | K941944 |
Device Name: | TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE |
Classification | Laparoscope, Gynecologic (and Accessories) |
Applicant | TAHOE SURGICAL INSTRUMENTS P.R., INC. P.O. BOX 1449 Vega Baja, PR 00694 -1449 |
Contact | Jon A Stevens |
Correspondent | Jon A Stevens TAHOE SURGICAL INSTRUMENTS P.R., INC. P.O. BOX 1449 Vega Baja, PR 00694 -1449 |
Product Code | HET |
CFR Regulation Number | 884.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-21 |
Decision Date | 1994-07-25 |