FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DESERET SURGEON'S GLOVE ACCESSORY
K Number: K823086
·
Decision Jan 17, 1983
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
556
Applicant Total
47
Review Days
90
Basic Information
- Device Name
- DESERET SURGEON'S GLOVE ACCESSORY
- K Number
- K823086
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- PARKE-DAVIS CO.
- Date Received
- October 19, 1982
- Decision Date
- January 17, 1983
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
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Other Clearances by PARKE-DAVIS CO.
| K Number | Device Name | ||
|---|---|---|---|
| K861725 | INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT | Dec 4, 1986 | Substantially Equivalent |
| K862119 | DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR | Aug 29, 1986 | Substantially Equivalent |
| K855120 | ATI DISPOSABLE BIOLOGICAL TEST PACK | Jun 18, 1986 | Substantially Equivalent |
| K860570 | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE | Mar 31, 1986 | Substantially Equivalent |
| K860290 | VIAPIC CENTRAL LINE CATHETER | Mar 18, 1986 | Substantially Equivalent |
| K852192 | DISPOSABLE STEAM BIOLOGICAL TEST PACK | Nov 1, 1985 | Substantially Equivalent |
| K841967 | DESERET THERMODILUTION CARDIAC OUTPUT | Aug 19, 1985 | Substantially Equivalent |
| K851327 | DESERET ARTERIAL CATHETER | Jun 14, 1985 | Substantially Equivalent |
| K852078 | SPECTRUM(TENTATIVE) | Jun 7, 1985 | Substantially Equivalent |
| K844840 | DESERET INTRODUCER SET | May 16, 1985 | Substantially Equivalent |