FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT ELECTROSURGICAL GROUNDING PAD
K Number: K780405
·
Decision Apr 5, 1978
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
6
Review Days
23
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Basic Information
- Device Name
- INFANT ELECTROSURGICAL GROUNDING PAD
- K Number
- K780405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- New Dimensions IN Medicine, Inc.
- Date Received
- March 13, 1978
- Decision Date
- April 5, 1978
- Product Code
- JOS
- 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 |
|---|---|---|---|
| JOS | Electrode, Electrosurgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by New Dimensions IN Medicine, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K920677 | CLEARSITE HYDROGEL WOUND DRESSING MODIFICATION | Apr 21, 1992 | Substantially Equivalent |
| K832145 | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE | Jul 19, 1983 | Substantially Equivalent |
| K822077 | RESPIRATION MONITOR TYPE MR-10 | Oct 6, 1982 | Substantially Equivalent |
| K780631 | NDM INFANT ECG PACKPAD | May 3, 1978 | Substantially Equivalent |
| K771749 | AMALGAM DISPENSER | Sep 28, 1977 | Substantially Equivalent |