CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15

Plasma, Coagulation Factor Deficient

PRECISION BIOLOGIC

The following data is part of a premarket notification filed by Precision Biologic with the FDA for Cryo Check Factor 2 Deficient Plasma, Models Fdpo2-10, Fdp02-15.

Pre-market Notification Details

• Device ID: K990814
• 510k Number: K990814
• Device Name: CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
• Classification: Plasma, Coagulation Factor Deficient
• Applicant: PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7
• Contact: Sandy Morrison
• Correspondent: Sandy Morrison; PRECISION BIOLOGIC 900 WINDMILL RD., SUITE 100 Dartmouth, N.s., CA B3b 1p7
• Product Code: GJT
• CFR Regulation Number: 864.7290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-03-11
• Decision Date: 1999-06-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00843876000220	K990814	000
00843876000213	K990814	000