FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FOLEY CATHETERIZATION TRAY
K Number: K790254
·
Decision Apr 10, 1979
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
59
Applicant Total
16
Review Days
63
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Basic Information
- Device Name
- FOLEY CATHETERIZATION TRAY
- K Number
- K790254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5130
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Snyder Laboratories, Inc.
- Date Received
- February 6, 1979
- Decision Date
- April 10, 1979
- Product Code
- FCM
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Snyder Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843906 | SNYDER HEMOVAC WOUND DRAINAGE DEVICES | Nov 5, 1984 | Substantially Equivalent |
| K821321 | SNYDER DEBRIBEMENT SYSTEM LDP-1 | Aug 6, 1982 | Substantially Equivalent |
| K800861 | SNYDER HEMOVAC CHEST DRAINAGE SOLUTION | May 2, 1980 | Substantially Equivalent |
| K800543 | SNYDER HYSTERECTOMY Y TUBE KIT | Apr 16, 1980 | Substantially Equivalent |
| K800577 | SNYDER HEMOVAC TM VENTED WOUND KIT | Apr 16, 1980 | Substantially Equivalent |
| K800578 | SURGIVAC TM | Apr 16, 1980 | Substantially Equivalent |
| K800542 | 100 ML SNYDER HEMOVAC | Apr 2, 1980 | Substantially Equivalent |
| K790607 | GREENLINE IRRIGATION TRAYS | May 11, 1979 | Substantially Equivalent |
| K790606 | CATHETERS, GREENLINE SUCTION | Apr 23, 1979 | Substantially Equivalent |
| K790420 | SUCTION CONNECTING TUBING | Apr 23, 1979 | Substantially Equivalent |