FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NON-STERILE PREGELLED GROUNDING PAD
K Number: K761221
·
Decision Jan 12, 1977
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
23
Review Days
36
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Basic Information
- Device Name
- NON-STERILE PREGELLED GROUNDING PAD
- K Number
- K761221
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Ipco Corp.
- Date Received
- December 7, 1976
- Decision Date
- January 12, 1977
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Ipco Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871270 | PERFORM DENTURE BASE RESIN | May 29, 1987 | Substantially Equivalent |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | May 29, 1985 | Substantially Equivalent |
| K850906 | TACTILE PLUS DENTAL ELEVATORS | Apr 12, 1985 | Substantially Equivalent |
| K842836 | SAFE & SOFT MINI PADS & MAXI PADS | Oct 15, 1984 | Substantially Equivalent |
| K842837 | SAFE & SOFT MAXI SHILEDS | Oct 15, 1984 | Substantially Equivalent |
| K842838 | SAFE & SOFT PANTY SHIELDS | Oct 5, 1984 | Substantially Equivalent |
| K841953 | ULTRA SHIELD BRIEFS | Jul 19, 1984 | Substantially Equivalent |
| K840753 | AMBEZE DISPOSABLE INCONTINENCE PANTS | Apr 13, 1984 | Substantially Equivalent |
| K840754 | MAXISHIELD INCONTINENCE CARE SYSTEM | Apr 13, 1984 | Substantially Equivalent |
| K840755 | MINIGARD DISPOSABLE LINERS | Apr 13, 1984 | Substantially Equivalent |