FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREP SHAVE KIT (NON-STERILE)
K Number: K925016
·
Decision Apr 26, 1993
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
109
Applicant Total
36
Review Days
214
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Basic Information
- Device Name
- PREP SHAVE KIT (NON-STERILE)
- K Number
- K925016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Customed, Inc.
- Date Received
- September 24, 1992
- Decision Date
- April 26, 1993
- Product Code
- LRO
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Customed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | Jan 5, 1998 | Substantially Equivalent |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | Dec 4, 1997 | Substantially Equivalent |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Nov 25, 1996 | Unknown |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Oct 4, 1996 | Substantially Equivalent |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Sep 27, 1996 | Substantially Equivalent |
| K961442 | UNIVERSAL DRAINAGE TRAY | May 9, 1996 | Substantially Equivalent |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | Oct 2, 1995 | Substantially Equivalent |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Apr 18, 1995 | Substantially Equivalent |
| K942177 | FOLEY CATHETERIZATION TRAY | Sep 8, 1994 | Substantially Equivalent |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | Aug 27, 1993 | Unknown |