FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OR TOWEL
K Number: K941802
·
Decision May 3, 1995
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
8
Review Days
386
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Basic Information
- Device Name
- OR TOWEL
- K Number
- K941802
- 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
- Hermitage Hospital Products, Inc.
- Date Received
- April 12, 1994
- Decision Date
- May 3, 1995
- 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 Hermitage Hospital Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923115 | CLINISORB | Nov 23, 1992 | Substantially Equivalent |
| K923116 | COMBINE II WETPROOF PAD | Oct 6, 1992 | Substantially Equivalent |
| K891324 | HERMITEX SPONGE | Apr 27, 1989 | Substantially Equivalent |
| K863737 | SPONGES STERILE TWIN PAKT AND SINGLES | Oct 14, 1986 | Substantially Equivalent |
| K843788 | CUSTOM BURN DRESSING KIT | Nov 7, 1984 | Substantially Equivalent |
| K822987 | DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |
| K822623 | LAPAROTOMY SPONGE | Oct 13, 1982 | Substantially Equivalent |