The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Bioabsorbable Bankart Tack.
| Device ID | K973849 |
| 510k Number | K973849 |
| Device Name: | BIOABSORBABLE BANKART TACK |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-08 |
| Decision Date | 1998-01-06 |
| Summary: | summary |