FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PARKE-DAVIS SURGICAL LIGHT
K Number: K801353
·
Decision Jun 30, 1980
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
28
Applicant Total
50
Review Days
21
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PARKE-DAVIS SURGICAL LIGHT
- K Number
- K801353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Warner-Lambert Co.
- Date Received
- June 9, 1980
- Decision Date
- June 30, 1980
- Product Code
- FTD
- 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 |
|---|---|---|---|
| FTD | Lamp, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FTD), ordered by most recent decision date.
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VOLISTA 400; VOLISTA 600
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
POLARIS 100/200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ATRICURE DISSECTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HM-LAMP II
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
STRYKER KNIFELIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Warner-Lambert Co.
| K Number | Device Name | ||
|---|---|---|---|
| K024160 | NEOSPORIN SCAR SOLUTION | Mar 17, 2003 | Substantially Equivalent |
| K893452 | EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM | Jun 22, 1989 | Substantially Equivalent |
| K870584 | O.P.T.(TM) OVULATION PREDICTION TEST | Nov 25, 1987 | Substantially Equivalent |
| K861510 | MULTILUMEN VIAPIC CENTRAL LINE CATHETER | Jun 9, 1986 | Substantially Equivalent |
| K852689 | GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK | Aug 19, 1985 | Substantially Equivalent |
| K852967 | GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK | Aug 19, 1985 | Substantially Equivalent |
| K852843 | GENERAL DIAGNOSTICS COAG-A-MATE XC | Aug 13, 1985 | Substantially Equivalent |
| K852889 | GENERAL DIAGNOSTICS RAPID E. COLI TEST | Jul 23, 1985 | Substantially Equivalent |
| K850409 | GEN. DIAG. CHROMOSTRATE REF. PLASMA | May 8, 1985 | Substantially Equivalent |
| K850412 | GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY | May 8, 1985 | Substantially Equivalent |