FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NASO-GARD NASOGASTRIC TUBE HOLDER
K Number: K822443
·
Decision Sep 2, 1982
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
64
Review Days
17
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Basic Information
- Device Name
- NASO-GARD NASOGASTRIC TUBE HOLDER
- K Number
- K822443
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- August 16, 1982
- Decision Date
- September 2, 1982
- 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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Other Clearances by American Pharmaseal Div. Ahsc
| K Number | Device Name | ||
|---|---|---|---|
| K874022 | PHARMASEAL WOUND IRRIGATION DEVICE | Dec 30, 1987 | Substantially Equivalent |
| K874517 | PHARMASEAL RUBBER URETHRAL CATHETER | Dec 3, 1987 | Substantially Equivalent |
| K874045 | PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER | Dec 3, 1987 | Substantially Equivalent |
| K873359 | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE | Nov 6, 1987 | Substantially Equivalent |
| K872228 | PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872917 | JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER | Aug 11, 1987 | Substantially Equivalent |
| K871429 | ANTIMICROBIAL FOLEY CATHETER | Aug 10, 1987 | Substantially Equivalent |
| K871770 | AMERICAN PHARMASEAL WOUND DRESSING | Jun 26, 1987 | Substantially Equivalent for Some Indications |
| K870387 | EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE | May 8, 1987 | Substantially Equivalent |
| K870977 | PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE | Apr 1, 1987 | Substantially Equivalent |