The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Medila H.
Device ID | K983963 |
510k Number | K983963 |
Device Name: | DORNIER MEDILA H |
Classification | Powered Laser Surgical Instrument |
Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
Contact | Carol Wernecke |
Correspondent | Carol Wernecke DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-06 |
Decision Date | 1998-11-25 |
Summary: | summary |