FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COMPOUND BENZOIN TINCTURE USP SEPP
K Number: K923516
·
Decision Jan 25, 1994
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
13
Review Days
586
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Basic Information
- Device Name
- COMPOUND BENZOIN TINCTURE USP SEPP
- K Number
- K923516
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medi-Flex Hospital Products, Inc.
- Date Received
- June 18, 1992
- Decision Date
- January 25, 1994
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Medi-Flex Hospital Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K970441 | K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH | May 9, 1997 | Substantially Equivalent |
| K962740 | DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641 | Sep 6, 1996 | Substantially Equivalent |
| K952201 | PORT-A-CATH ACCESS KIT | Oct 4, 1995 | Substantially Equivalent |
| K952416 | TRACHEOSTOMY CARE KIT | Aug 9, 1995 | Unknown |
| K952256 | PICC LINE KIT | Jul 31, 1995 | Substantially Equivalent |
| K952007 | ADHEROL SEPP APPLICATOR | Jun 8, 1995 | Substantially Equivalent |
| K934790 | SEPP ADHESIVE REMOVER | Mar 11, 1994 | Substantially Equivalent |
| K920399 | COMPOUND BENZOIN TINCTURE USP FREPP | Jan 25, 1994 | Substantially Equivalent |
| K930196 | CEPTI-SEAL I.V. PREP KIT | Jul 2, 1993 | Unknown |
| K921347 | CEPTI-SEAL DRESSING CHANGE KIT FOR VENOUS CATHETER | Jan 8, 1993 | Unknown |