PEREGRINE 23GA CURVED LASER PROBE

Photocoagulator And Accessories

PEREGRINE SURGICAL, LTD.

The following data is part of a premarket notification filed by Peregrine Surgical, Ltd. with the FDA for Peregrine 23ga Curved Laser Probe.

Pre-market Notification Details

Device IDK122905
510k NumberK122905
Device Name:PEREGRINE 23GA CURVED LASER PROBE
ClassificationPhotocoagulator And Accessories
Applicant PEREGRINE SURGICAL, LTD. 51 Britain Drive Doylestown,  PA  18901
ContactRyan O'leary
CorrespondentRyan O'leary
PEREGRINE SURGICAL, LTD. 51 Britain Drive Doylestown,  PA  18901
Product CodeHQB  
CFR Regulation Number886.4690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-21
Decision Date2013-04-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10632307002165 K122905 000
10632307000949 K122905 000
10757770507655 K122905 000
10757770507648 K122905 000
10757770507532 K122905 000
10757770507525 K122905 000
10757770507518 K122905 000
10757770507501 K122905 000

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