The following data is part of a premarket notification filed by Physician & Nurses Mfg. Corp. with the FDA for Physi. & Nurses Brand Instant Kold & Hot Kompress.
| Device ID | K863507 |
| 510k Number | K863507 |
| Device Name: | PHYSI. & NURSES BRAND INSTANT KOLD & HOT KOMPRESS |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | PHYSICIAN & NURSES MFG. CORP. P.O. BOX 68 Larchmont, NY 10538 |
| Contact | James D Hogan |
| Correspondent | James D Hogan PHYSICIAN & NURSES MFG. CORP. P.O. BOX 68 Larchmont, NY 10538 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-09 |
| Decision Date | 1986-09-19 |