The following data is part of a premarket notification filed by Hobbs Medical, Inc. with the FDA for Pressure Gauge.
| Device ID | K921026 |
| 510k Number | K921026 |
| Device Name: | PRESSURE GAUGE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Contact | Robert G Whalen |
| Correspondent | Robert G Whalen HOBBS MEDICAL, INC. P.O. BOX 46 SPRING STREET Stafford Springs, CT 06076 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M84946300 | K921026 | 000 |