The following data is part of a premarket notification filed by Adler Instrument Co. with the FDA for Adler Disposable Bipolar Cord.
Device ID | K900913 |
510k Number | K900913 |
Device Name: | ADLER DISPOSABLE BIPOLAR CORD |
Classification | Unit, Cautery, Thermal, Ac-powered |
Applicant | ADLER INSTRUMENT CO. 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Contact | Norman Black |
Correspondent | Norman Black ADLER INSTRUMENT CO. 6191 ATLANTIC BLVD. Norcross, GA 30071 |
Product Code | HQO |
CFR Regulation Number | 886.4115 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-27 |
Decision Date | 1990-04-04 |