FDA 510(k) FDA class 1 Substantially Equivalent for Some Indications 🇺🇸 United States

BEAVER R-K KNIFE

K Number: K852828 · Decision Nov 4, 1985
Classifications
1
FEI Numbers
206
Registration Numbers
207
Same Product Code
53
Applicant Total
6
Review Days
125

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
BEAVER R-K KNIFE
K Number
K852828
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.4350
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent for Some Indications
Applicant
Rudolph Beaver, Inc.
Date Received
July 2, 1985
Decision Date
November 4, 1985
Product Code
HNN
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HNN Knife, Ophthalmic

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (HNN), ordered by most recent decision date.

View all

Other Clearances by Rudolph Beaver, Inc.

K Number Device Name
K883361 ARTHRO-TRAC(TM)
K875030 OCU-1
K862709 MECHANICAL CYSTITOME
K860305 BEAVER MICRO-GEM GAUGE BLOCK
K853129 BEAVER MULTIPURPOSE SAPPHIRE KNIFE