FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RETROBULBAR NEEDLE
K Number: K873848
·
Decision Oct 23, 1987
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
47
Applicant Total
9
Review Days
31
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Basic Information
- Device Name
- RETROBULBAR NEEDLE
- K Number
- K873848
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Healthtek, Inc.
- Date Received
- September 22, 1987
- Decision Date
- October 23, 1987
- Product Code
- GDM
- 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 |
|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Healthtek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG | Jul 28, 1993 | Substantially Equivalent |
| K913985 | TRANSFER-AID(TM) | Mar 18, 1992 | Substantially Equivalent |
| K913608 | SNAPPER | Nov 29, 1991 | Substantially Equivalent |
| K881590 | ADFUSE(TM) | May 23, 1988 | Substantially Equivalent |
| K874495 | ADCOMP 4000 HP SYSTEM | Feb 16, 1988 | Substantially Equivalent |
| K860610 | ADCOMP | Jul 8, 1986 | Substantially Equivalent |
| K860372 | FAST FLOW XX (AQUEOUS SOLUTION FILTER) | May 30, 1986 | Substantially Equivalent |
| K854008 | STATLOCK | Nov 13, 1985 | Substantially Equivalent |