FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMSTATS
K Number: K844152
·
Decision Nov 7, 1984
Classifications
1
FEI Numbers
182
Registration Numbers
182
Same Product Code
14
Applicant Total
41
Review Days
14
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Basic Information
- Device Name
- HEMSTATS
- K Number
- K844152
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- I M, Inc.
- Date Received
- October 24, 1984
- Decision Date
- November 7, 1984
- Product Code
- HRQ
- 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 |
|---|---|---|---|
| HRQ | Hemostat | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRQ), ordered by most recent decision date.
DISPOSABLE HEMOSTATS
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BERNARD VESSEL APPROXIMATOR
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SURGICAL HEMOSTATS
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FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by I M, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914600 | NEUROLOGICAL SPONGE | Dec 30, 1992 | Substantially Equivalent |
| K892389 | BIOPSY KIT | Jul 17, 1989 | Unknown |
| K881363 | SYRINGE PREFILLED WITH WATER | Jun 23, 1988 | Substantially Equivalent |
| K880753 | UMBILICAL CORD CLAMP | Apr 27, 1988 | Substantially Equivalent |
| K872741 | NUTRIPUMP | Oct 20, 1987 | Substantially Equivalent |
| K871495 | BANDAGES CATALOG NUMBER: 101 TO 220 | May 8, 1987 | Substantially Equivalent |
| K863785 | MAKLER CATHETER | Dec 11, 1986 | Substantially Equivalent |
| K854155 | STERILE SALINE SOLUTION | Dec 10, 1985 | Substantially Equivalent |
| K853287 | HUBOUT | Oct 17, 1985 | Substantially Equivalent |
| K853288 | FEEDING UNITS & TUBES | Oct 4, 1985 | Substantially Equivalent |