FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROBE RETRACTOR, PART #S-2L8-6
K Number: K770414
·
Decision Apr 15, 1977
Classifications
1
FEI Numbers
658
Registration Numbers
658
Same Product Code
99
Applicant Total
27
Review Days
42
Basic Information
- Device Name
- PROBE RETRACTOR, PART #S-2L8-6
- K Number
- K770414
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- ACME UNITED CORP.
- Date Received
- March 4, 1977
- Decision Date
- April 15, 1977
- Product Code
- GAD
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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Other Clearances by ACME UNITED CORP.
| K Number | Device Name | ||
|---|---|---|---|
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| K952565 | LYOFOAM EXTRA | Nov 14, 1995 | Substantially Equivalent for Some Indications |
| K895764 | MODIFIED LYOFOAM WOUND DRESSINGS | Sep 10, 1990 | Substantially Equivalent for Some Indications |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Jun 9, 1987 | Substantially Equivalent |
| K864084 | LYOFOAM C ODOR-ABSORBING DRESSING | Nov 21, 1986 | Substantially Equivalent for Some Indications |
| K860085 | LYOFOAM WOUND DRESSINGS | Jun 27, 1986 | Substantially Equivalent for Some Indications |
| K860818 | ONE TIME ENTERAL FEEDING BAG | May 15, 1986 | Substantially Equivalent |
| K861015 | ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS | Apr 22, 1986 | Substantially Equivalent |
| K842186 | ACU-DERM TRANSPARENT WOUND DRESSING | Aug 24, 1984 | Substantially Equivalent |