The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Hobbs Mistifier Spray Catheter.
| Device ID | K030765 |
| 510k Number | K030765 |
| Device Name: | HOBBS MISTIFIER SPRAY CATHETER |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | HOBBS MEDICAL, INC. 8 SPRING ST. P.O. BOX 46 Stafford Springs, CT 06076 |
| Contact | Rob Whalen |
| Correspondent | Rob Whalen HOBBS MEDICAL, INC. 8 SPRING ST. P.O. BOX 46 Stafford Springs, CT 06076 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-11 |
| Decision Date | 2003-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M84921911 | K030765 | 000 |
| M84921901 | K030765 | 000 |