The following data is part of a premarket notification filed by Avid N.i.t., Inc. with the FDA for N,i.t., Inc. Automatic Cutting Biopsy Needle.
Device ID | K983218 |
510k Number | K983218 |
Device Name: | N,I.T., INC. AUTOMATIC CUTTING BIOPSY NEEDLE |
Classification | Biopsy Needle |
Applicant | AVID N.I.T., INC. 390 SCARLET BLVD. Oldsmar, FL 34677 |
Contact | Joseph E Harms |
Correspondent | Joseph E Harms AVID N.I.T., INC. 390 SCARLET BLVD. Oldsmar, FL 34677 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-14 |
Decision Date | 1998-11-06 |
Severity: Core Warning
Message: Module 'zip' already loaded
Filename: Unknown
Line Number: 0
Backtrace: