FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED
K Number: K914140
·
Decision Mar 31, 1992
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
38
Applicant Total
6
Review Days
197
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Basic Information
- Device Name
- GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED
- K Number
- K914140
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6900
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bissell Medical Products, Inc.
- Date Received
- September 16, 1991
- Decision Date
- March 31, 1992
- Product Code
- FPP
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPP | Stretcher, Hand-Carried | FDA class 1 | General Hospital |
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Other Clearances by Bissell Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932880 | GRASSI GASTROJEJUNOSTOMY TUBE | Jun 7, 1995 | Substantially Equivalent |
| K901683 | IMPROVED BAKER TWIN-CUFF SUMP TUBE | Jun 27, 1990 | Substantially Equivalent |
| K873441 | BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE | Oct 27, 1987 | Substantially Equivalent |
| K871691 | MODIFIED MULTI-LUMEN NASOGASTRIC TUBE | Aug 10, 1987 | Substantially Equivalent |
| K851672 | NYHUS/NELSON TUBE | Jul 9, 1985 | Substantially Equivalent |