FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUSE STAFF PROTECTION GOWNS AND KITS
K Number: K941845
·
Decision May 10, 1995
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
67
Applicant Total
31
Review Days
391
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Basic Information
- Device Name
- BUSE STAFF PROTECTION GOWNS AND KITS
- K Number
- K941845
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Busse Hospital Disposables, Inc.
- Date Received
- April 14, 1994
- Decision Date
- May 10, 1995
- Product Code
- FYC
- 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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Busse Hospital Disposables, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120002 | I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE | Jun 26, 2012 | Substantially Equivalent |
| K093909 | BUSSE SURGICAL DRAPES IV | May 6, 2010 | Substantially Equivalent |
| K092212 | BUSSE SURGICAL DRAPES III | Oct 9, 2009 | Substantially Equivalent |
| K082297 | BUSSE SURGICAL DRAPE | Dec 9, 2008 | Substantially Equivalent |
| K073222 | MODIFICATION TO:SPECIALTY NEEDLES | Apr 9, 2008 | Substantially Equivalent |
| K070465 | BUSSE EPIDURAL CATHETER | Jul 19, 2007 | Substantially Equivalent |
| K063018 | GLASS LOSS OF RESISTANCE SYRINGE | Jan 22, 2007 | Substantially Equivalent |
| K061394 | SPECIALTY NEEDLES (SPINAL NEEDLE, PENCIL POINT SPINAL NEEDLE, EPIDURAL NEEDLE) | Sep 6, 2006 | Substantially Equivalent |
| K061570 | I-STYLE BONE MARROW ASPIRATION NEEDLE | Jul 3, 2006 | Substantially Equivalent |
| K052843 | BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE | Apr 17, 2006 | Substantially Equivalent |