The following data is part of a premarket notification filed by Hood Laboratories with the FDA for Gibson Endolymphatic Shunt.
| Device ID | K897049 |
| 510k Number | K897049 |
| Device Name: | GIBSON ENDOLYMPHATIC SHUNT |
| Classification | Tube, Shunt, Endolymphatic |
| Applicant | HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Contact | Lewis H Marten |
| Correspondent | Lewis H Marten HOOD LABORATORIES 575 WASHINGTON ST. Pembroke, MA 02359 |
| Product Code | ESZ |
| CFR Regulation Number | 874.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-18 |
| Decision Date | 1990-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815347023601 | K897049 | 000 |
| 00815347023588 | K897049 | 000 |