The following data is part of a premarket notification filed by Porges Corp. with the FDA for Porges Hot Biopsy Forceps.
Device ID | K896537 |
510k Number | K896537 |
Device Name: | PORGES HOT BIOPSY FORCEPS |
Classification | Forceps, Biopsy, Electric |
Applicant | PORGES CORP. 5700 WEST 23RD AVE. Gary, IN 46406 |
Contact | Harry M Kaufman |
Correspondent | Harry M Kaufman PORGES CORP. 5700 WEST 23RD AVE. Gary, IN 46406 |
Product Code | KGE |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-15 |
Decision Date | 1989-11-30 |