FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CUSTOM INSTRUMENT DRAPE
K Number: K843890
·
Decision Oct 26, 1984
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
3
Applicant Total
23
Review Days
24
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Basic Information
- Device Name
- CUSTOM INSTRUMENT DRAPE
- K Number
- K843890
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Lifestream Int'L, Inc.
- Date Received
- October 2, 1984
- Decision Date
- October 26, 1984
- Product Code
- HMW
- 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 |
|---|---|---|---|
| HMW | Drape, Microscope, Ophthalmic | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HMW), ordered by most recent decision date.
INVOTEC MICROSCOPE DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STERILE INSTRUMENT DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MICROSCOPE DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Lifestream Int'L, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964571 | VISION CARDIOPLEGIA DELIVERY SYSTEM | Aug 8, 1997 | Substantially Equivalent |
| K962354 | DIOMED 15, 30, 60 SURGICAL DIODE LASER | Sep 11, 1996 | Substantially Equivalent |
| K920178 | CARDIOTOMY RESERVOIR W/20 MICRON FILITER | May 13, 1993 | Substantially Equivalent |
| K920618 | AUTOTRANSFUSION SUCTION SET | Mar 12, 1993 | Substantially Equivalent |
| K913181 | AUTOLOGOUS BLOOD PROCESSING SYSTEM | May 20, 1992 | Substantially Equivalent |
| K914396 | SURGI LIGHT NON-CONTACT FIBERS | Dec 23, 1991 | Substantially Equivalent |
| K912045 | TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST | Oct 31, 1991 | Substantially Equivalent |
| K911523 | MODIFICATION TO MODEL 90-1460 LASER ADAPTER | Apr 22, 1991 | Substantially Equivalent |
| K910726 | LIGHT-TOUCH AND SURGI LIGHT FIBERS | Mar 29, 1991 | Substantially Equivalent |
| K904491 | TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000 | Feb 1, 1991 | Substantially Equivalent |