FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAKE N/G FEEDING TUBE
K Number: K884127
·
Decision Feb 8, 1989
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
15
Review Days
131
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Basic Information
- Device Name
- LAKE N/G FEEDING TUBE
- K Number
- K884127
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Lake Medical Products, Inc.
- Date Received
- September 30, 1988
- Decision Date
- February 8, 1989
- Product Code
- KNT
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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ZZIREN Orogastric Tube; ZZIREN SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)
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Other Clearances by Lake Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943162 | LAKE STAGEZERO(TM) AIR FLOTATION BED | Feb 27, 1995 | Substantially Equivalent |
| K922730 | LAKE OSTOMY CARE SET | Dec 30, 1993 | Unknown |
| K905053 | STAGE ZERO AIR FLOTATION BED | Nov 26, 1990 | Substantially Equivalent |
| K901835 | LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR) | Sep 5, 1990 | Substantially Equivalent |
| K902508 | LAKE MALE EXTERNAL CATHETERIZATION KIT | Aug 23, 1990 | Unknown |
| K902121 | LAKE GASTROSTOMY TUBE | Jul 27, 1990 | Substantially Equivalent |
| K884128 | LAKE N/G EXTENSION SET | Dec 8, 1988 | Substantially Equivalent |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Oct 12, 1988 | Substantially Equivalent |
| K880578 | LAKE DISPOSABLE PROBE COVER | Mar 31, 1988 | Substantially Equivalent |
| K875383 | LAKE CATHETER CARE KITS (MODIFICATION) | Mar 9, 1988 | Unknown |