The following data is part of a premarket notification filed by Biocomposites Ltd. with the FDA for Stimulan Kit, Stimulan Rapid Cure.
Device ID | K141830 |
510k Number | K141830 |
Device Name: | STIMULAN KIT, STIMULAN RAPID CURE |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
Contact | Marie Whalley |
Correspondent | Simon Fitzer BIOCOMPOSITES LTD. KEELE SCIENCE PARK Keele, Staffordshire, GB St5 5nl |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-07 |
Decision Date | 2015-01-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50601557110416 | K141830 | 000 |
15060155711543 | K141830 | 000 |
15060155711550 | K141830 | 000 |
15060155711567 | K141830 | 000 |
15060155711574 | K141830 | 000 |
50601557101124 | K141830 | 000 |
50601557101292 | K141830 | 000 |
50601557110270 | K141830 | 000 |
50601557110348 | K141830 | 000 |
15060155711536 | K141830 | 000 |