FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K Number: K934445
·
Decision Apr 11, 1994
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
101
Review Days
210
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Basic Information
- Device Name
- STSTORZ DP5300 AND DP9502 STERILE DRAPES
- K Number
- K934445
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Storz Instrument Co.
- Date Received
- September 13, 1993
- Decision Date
- April 11, 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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|---|---|---|---|
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| K972664 | STORZ MILLENNIUM VISCOUS FLUID SYSTEM | Oct 10, 1997 | Substantially Equivalent |
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| K964743 | STORZ E8010 ERGOTEC/PREMIERE ADAPTOR | Feb 3, 1997 | Substantially Equivalent |
| K960024 | STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH | Sep 20, 1996 | Substantially Equivalent |
| K960061 | STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE | Sep 18, 1996 | Substantially Equivalent |
| K960003 | STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION | Aug 29, 1996 | Substantially Equivalent |
| K962131 | STORZ D4600 AIR EXCHANGE LINE PACK | Aug 23, 1996 | Substantially Equivalent |
| K961831 | STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK | Aug 6, 1996 | Substantially Equivalent |