FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PDI SURGICAL SCRUB SPONGE-BRUSH-T15070
K Number: K810337
·
Decision Feb 26, 1981
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
36
Applicant Total
9
Review Days
17
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Basic Information
- Device Name
- PDI SURGICAL SCRUB SPONGE-BRUSH-T15070
- K Number
- K810337
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Nice-Pak Products, Inc.
- Date Received
- February 9, 1981
- Decision Date
- February 26, 1981
- Product Code
- GEC
- 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 |
|---|---|---|---|
| GEC | Brush, Scrub, Operating-Room | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Nice-Pak Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974768 | PDI STERILE LUBRICATING JELLY | Jan 16, 1998 | Substantially Equivalent |
| K840342 | PDI PREPMASTER WET PACK PATIENT PREP KIT | Mar 27, 1984 | Substantially Equivalent |
| K840343 | PDI PREPMASTER WET PACK VAGINAL-X21477 | Mar 27, 1984 | Substantially Equivalent |
| K840344 | PDI PREPMASTER WET PACK MINOR PROCEDURE | Mar 26, 1984 | Substantially Equivalent |
| K833549 | PDI SURGICAL SCRUB/BRUSH T150-70 | Nov 28, 1983 | Substantially Equivalent |
| K781539 | ISO-CARE KIT | Nov 3, 1978 | Substantially Equivalent |
| K780279 | ICE-PAK, PDI | Apr 10, 1978 | Substantially Equivalent |
| K780400 | DEN-Z-ORB | Mar 27, 1978 | Substantially Equivalent |