FDA 510(k)
Substantially Equivalent
🇺🇸 United States
OMED DISPOS. INSTRUMENT GUARDS
K Number: K842603
·
Decision Sep 5, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
62
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Basic Information
- Device Name
- OMED DISPOS. INSTRUMENT GUARDS
- K Number
- K842603
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Omega-Med Intl., Inc.
- Date Received
- July 5, 1984
- Decision Date
- September 5, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Omega-Med Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832441 | SUTURE-AID BOOTIES | Mar 5, 1984 | Substantially Equivalent |
| K830484 | OMED IDENT-I-BAND | Mar 24, 1983 | Substantially Equivalent |
| K822284 | COMPLY NEUROMUSCULAR STIMULATOR | Sep 17, 1982 | Substantially Equivalent |
| K821334 | OMED FABRIC INSTRUMENT COVERS-RADIOPAQ | May 24, 1982 | Substantially Equivalent |
| K813499 | OMED DISPOSABLE BULLDOG | Dec 29, 1981 | Substantially Equivalent |
| K810883 | OMED SILICONE INSTRUMENT COVERS | Apr 23, 1981 | Substantially Equivalent |
| K810269 | OMED FABRIC INSTRUMENT COVERS | Feb 26, 1981 | Substantially Equivalent |
| K810260 | OMED SILICONE LOOPS | Feb 26, 1981 | Substantially Equivalent |