The following data is part of a premarket notification filed by Bossong Hosiery Mills, Inc with the FDA for Bossong Hosiery Medical Compression Stockings 8-15 Mmhg, Bossong Hosiery Anti-embolism Stockings 10-20 Mmhg, Bossong Hos.
Device ID | K123820 |
510k Number | K123820 |
Device Name: | BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | BOSSONG HOSIERY MILLS, INC 3855 8TH STREET PLACE NW Hickory, NC 28601 |
Contact | Roger Rand |
Correspondent | Roger Rand BOSSONG HOSIERY MILLS, INC 3855 8TH STREET PLACE NW Hickory, NC 28601 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-12 |
Decision Date | 2013-04-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00311917014227 | K123820 | 000 |
00311917014210 | K123820 | 000 |
00311917014050 | K123820 | 000 |
00311917014029 | K123820 | 000 |
00311917013992 | K123820 | 000 |