The following data is part of a premarket notification filed by Hardwood Products Co., Lp with the FDA for Puritan Foam Tip Swab Model 2197.
| Device ID | K961934 |
| 510k Number | K961934 |
| Device Name: | PURITAN FOAM TIP SWAB MODEL 2197 |
| Classification | Spatula, Cervical, Cytological |
| Applicant | HARDWOOD PRODUCTS CO., LP P.O. BOX 149, 31 SCHOOL ST. Guilford, ME 04443 |
| Contact | William M Young |
| Correspondent | William M Young HARDWOOD PRODUCTS CO., LP P.O. BOX 149, 31 SCHOOL ST. Guilford, ME 04443 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-07-09 |
| Summary: | summary |