510(k) K934080
- Device
- URINARY DRAINAGE BAG
- Applicant
- KIT PAK, INC.
- 510(k) number
- K934080
- Product code
- EYT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-05-18
- Date received
- 1993-08-20
- Regulation
- 876.5250
- Classification name
- Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS J SANDERS
- Address
- 825 Chase Ave. Elk Grove Village IL US 60007 60007
FDA Registration Numbers#
- 8022890
- 3003965134
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EYT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935774 | CURITY FAST-CATH FEMALE CATHETER KIT | Kendall Healthcare Products Co. Div.Of Tyco Health | 1994-04-11 |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | Sierra Laboratories, Inc. | 1988-08-02 |
| K883119 | VPI NON-ADHESIVE CONDOM CATHETER | Cook Urological, Inc. | 1988-08-02 |
Legacy Summary#
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FDA Review#
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