FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UPPER EXTERMITY DRAPE KIT
K Number: K923960
·
Decision Oct 7, 1994
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
8
Review Days
792
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Basic Information
- Device Name
- UPPER EXTERMITY DRAPE KIT
- K Number
- K923960
- 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
- Medikmark, Inc.
- Date Received
- August 6, 1992
- Decision Date
- October 7, 1994
- Product Code
- KKX
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Medikmark, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K953474 | IV START KIT | Oct 2, 1995 | Substantially Equivalent |
| K921730 | C-SECTION PACK | Jun 15, 1994 | Substantially Equivalent |
| K921733 | TRACHEOSTOMY CARE TRAY | Jun 15, 1994 | Unknown |
| K921732 | MINOR LAP SET | Jun 15, 1994 | Substantially Equivalent |
| K920339 | DRESSING CHANGE TRAY | Apr 23, 1992 | Unknown |
| K920341 | LACERATION TRAYS | Apr 23, 1992 | Unknown |
| K920340 | SUTURE REMOVAL KIT | Apr 23, 1992 | Unknown |