510(k) K892334
- Device
- LEONARD TUBE
- Applicant
- SURGIDYNE, INC.
- 510(k) number
- K892334
- Product code
- KDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-31
- Date received
- 1989-04-05
- Regulation
- 876.5980
- Classification name
- Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- B MCNEIL
- Address
- 9605 W. Jefferson Trl. Inver Grove Heights MN US 55077 55077
FDA Registration Numbers#
- 2011171
- 2028523
- 1423537
- 2029015
- 1643817
- 1921846
- 2029275
- 3009888344
- 3011270181
- 1314417
- 3009750712
- 2020735
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KDH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983624 | GILTECH PLUS CONNECTING TUBE SET | Giltech Plus, Inc. | 1999-03-18 |
| K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | Armm, Inc. | 1998-06-19 |
| K971259 | COMBIPORT FLUID LAVAGE DEVICE | B.Braun Medical, Inc. | 1997-10-27 |
| K962850 | TUM-E-VAC | Ethox Corp. | 1997-02-21 |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Ballard Medical Products | 1995-07-05 |
| K923497 | FLUSHING IRRIGATION SET | Orion Life Systems, Inc. | 1994-03-21 |
| K920619 | TRI-MED GASTRIC LAVAGE SYSTEM | Tri-Med Specialties, Inc. | 1992-09-04 |
| K920527 | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT | Tri-Med Specialties, Inc. | 1992-09-04 |
| K914908 | QUICVAGE PLUS | Autovage | 1992-04-13 |
| K914907 | QUICVAGE | Autovage | 1992-01-24 |
| K911788 | ECONOVAGE R | Autovage | 1991-07-26 |
| K911919 | MINIVAGE(R) | Autovage | 1991-07-26 |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | Biomedical Dynamics, Inc. | 1991-06-24 |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Gainor Medical Europe, Ltd. | 1990-11-20 |
| K900086 | HEMORRHOIDAL LIGATOR WITH SUCTION | Baxter Healthcare Corp | 1990-03-19 |
Legacy Summary#
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FDA Review#
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