FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STOMAHESIVE PASTE PROTECTIVE SKIN BARR
K Number: K803100
·
Decision Jan 8, 1981
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
5
Applicant Total
32
Review Days
30
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Basic Information
- Device Name
- STOMAHESIVE PASTE PROTECTIVE SKIN BARR
- K Number
- K803100
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- E. R. Squibb & Sons, Inc.
- Date Received
- December 9, 1980
- Decision Date
- January 8, 1981
- Product Code
- EZR
- 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 |
|---|---|---|---|
| EZR | Cement, Stomal Appliance, Ostomy | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EZR), ordered by most recent decision date.
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·Gastroenterology, Urology
Other Clearances by E. R. Squibb & Sons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821494 | RIA STAT 16 | Jun 3, 1982 | Substantially Equivalent |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | Mar 26, 1982 | Substantially Equivalent |
| K820340 | T3 UPTAKE-SQUIBB DIAGNOSTIC KIT | Mar 4, 1982 | Substantially Equivalent |
| K820341 | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT | Mar 4, 1982 | Substantially Equivalent |
| K811240 | SUR-FIT LOOP OSTOMY O.R. SET | Jun 16, 1981 | Substantially Equivalent |
| K811239 | SUR-FIT DISPOSABLE CONVEX INSERT | Jun 9, 1981 | Substantially Equivalent |
| K811160 | SUR-FIT IRRIGATION SLEEVE | Jun 2, 1981 | Substantially Equivalent |
| K811163 | SUR-FIT DISPOSABLE FANGE CAP | May 21, 1981 | Substantially Equivalent |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | Apr 21, 1981 | Substantially Equivalent |
| K810211 | T3 RIA KIT | Feb 10, 1981 | Substantially Equivalent |