FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CUSTOM BURN DRESSING KIT
K Number: K843788
·
Decision Nov 7, 1984
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- CUSTOM BURN DRESSING KIT
- K Number
- K843788
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Hermitage Hospital Products, Inc.
- Date Received
- September 27, 1984
- Decision Date
- November 7, 1984
- Product Code
- KGN
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by Hermitage Hospital Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941802 | OR TOWEL | May 3, 1995 | Substantially Equivalent |
| 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 |
| K822987 | DRESSING SPONGE | Nov 5, 1982 | Substantially Equivalent |
| K822623 | LAPAROTOMY SPONGE | Oct 13, 1982 | Substantially Equivalent |