The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Shielded Attachment.
Device ID | K974025 |
510k Number | K974025 |
Device Name: | ANSPACH SHIELDED ATTACHMENT |
Classification | Bur, Surgical, General & Plastic Surgery |
Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
Contact | William E Anspach Iii |
Correspondent | William E Anspach Iii THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
Product Code | GFF |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-10-23 |
Decision Date | 1998-07-06 |