The following data is part of a premarket notification filed by Georgia Biomedical Research Group, Inc. with the FDA for Ott Insufflation Filter Tubing.
| Device ID | K920205 |
| 510k Number | K920205 |
| Device Name: | OTT INSUFFLATION FILTER TUBING |
| Classification | Insufflator, Laparoscopic |
| Applicant | GEORGIA BIOMEDICAL RESEARCH GROUP, INC. 250 CHARTER LANE, STE. 101 Macon, GA 31210 |
| Contact | Douglas E Ott |
| Correspondent | Douglas E Ott GEORGIA BIOMEDICAL RESEARCH GROUP, INC. 250 CHARTER LANE, STE. 101 Macon, GA 31210 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-16 |
| Decision Date | 1993-10-25 |