The following data is part of a premarket notification filed by North Health Care with the FDA for Gauze Bandage 4 X 6 Yds..
| Device ID | K884335 |
| 510k Number | K884335 |
| Device Name: | GAUZE BANDAGE 4 X 6 YDS. |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | NORTH HEALTH CARE 1515 ELMWOOD RD. Rockford, IL 61103 |
| Contact | James Wright |
| Correspondent | James Wright NORTH HEALTH CARE 1515 ELMWOOD RD. Rockford, IL 61103 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-14 |
| Decision Date | 1989-01-09 |