The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Aspen Disposable Bipolar Cord.
Device ID | K893732 |
510k Number | K893732 |
Device Name: | ASPEN DISPOSABLE BIPOLAR CORD |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Contact | William W Abraham |
Correspondent | William W Abraham CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-17 |
Decision Date | 1989-07-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00653405987638 | K893732 | 000 |