The following data is part of a premarket notification filed by Georgia Biomedical, Inc. with the FDA for Filter Heater/hydrator Insufflation Gas Conditioner.
| Device ID | K970866 |
| 510k Number | K970866 |
| Device Name: | FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER |
| Classification | Insufflator, Laparoscopic |
| Applicant | GEORGIA BIOMEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J. M Nolte, Phd. |
| Correspondent | Cynthia J. M Nolte, Phd. GEORGIA BIOMEDICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1998-01-23 |
| Summary: | summary |