Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
2024439993
Device Listing 2024439993
Listing Summary
#
Listing key
2024439993
Premarket submission
K203640
Device
CoolSeal Reveal
Applicant
Bolder Surgical, LLC
Product code
GEI
Decision date
2021-05-06
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
82546
1222780
1000120743
HOLOGIC, INC.
1
Y
2026-01-01
250 Campus Dr Marlborough MA US 01752
98371
3007200016
3007200016
Hologic Surgical Products Costa Rica, S.R.L.
1
N
2026-01-01
562 Parkway, Ave 0, Calle 0 Coyol Free Zone El Coyol Alajuela CR 20102
342052
3010377594
3010377594
BOLDER SURGICAL, LLC
1
N
2026-01-01
331 S. 104th Street Suite 200 LOUISVILLE CO US 80027